Virologists push back on more regulation of viruses made more lethal in the lab

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An electron microscope image shows SARS-CoV-2. (Photo credit: NIH)

Virologists pushed back on the possibility of tighter regulation of viruses tweaked in the lab to be more lethal at a public meeting Wednesday.

An enhanced pandemic potential pathogen is a virus or microbe that has gained increased transmissibility —  capacity to spread from person to person and reverberate throughout a population —  or virulence — capacity to cause serious disease.

Experiments that are reasonably anticipated to generate deadlier pathogens are supposed to receive heightened oversight from the Department of Health and Human Services under what is nicknamed the HHS “P3CO,” short for the pandemic potential pathogen committee.

Though established just a few years ago, critics say the committee’s work is hidden from public view, suffers from glaring loopholes and needs a reboot. Work that contributes to vaccine development or results from viral surveillance efforts in nature is exempted from this extra layer of review, for example. 

Speculation by some in the U.S. intelligence community that SARS-CoV-2 may have seeped out of a lab at the pandemic’s epicenter may have prompted a public meeting to consider whether current policies are adequate. Reporting irregularities by a nonprofit partner of the lab involved in gain-of-function research on coronaviruses and funded by the National Institutes of Health called EcoHealth Alliance has also led many to conclude the P3CO needs to apply to more research projects and be more accountable to the public.

One million Americans have died of COVID-19. A review by the U.S. intelligence community last summer about whether the novel coronavirus spilled over from an animal or spilled out of a lab was inconclusive.

The Office of Science and Technology Policy and NIH cohosted the meeting Wednesday.

White House COVID-19 testing czar Tom Inglesby was harshly critical of the existing framework. His top recommendation: Scientists should be required to explain in detail the goals of undertaking such research in the first place, and why less perilous methods could not reach the same goal. 

“There must be an extraordinary and public justification,” he said. “I do think there are experiments we shouldn’t do.”

But lobbying groups representing virologists and other life scientists pushed back.

“The systems of review should not be a solution looking for a problem,” said Felicia Goodrum, president of the American Society for Virology. 

Goodrum said regulation risks “tying two hands behind our backs” when it comes to modeling pandemic risks. 

Goodrum added that the inherently unpredictable nature of manipulating viruses means that it’s unwieldy to determine whether or not an experiment will make a virus more dangerous, so the regulations should be lax.

“We must be careful about dichotomizing research as simply either ‘risky’ or not because it is not possible to absolutely predict the biology of a virus with the committee,” she said.  

But Gregory Koblentz, director of the biodefense graduate program at George Mason University, said that an EcoHealth Alliance grant that funded research that made coronaviruses more deadly by swapping their spike proteins is emblematic of lapses in oversight at NIH. 

The research was not regulated as gain-of-function work, but NIH did add language to the grant requiring extra reporting if the viral engineering led to viruses that were 10 times more pathogenic. (The chimeric viruses proved to be much more pathogenic than even that threshold, but EcoHealth Alliance did not report it.) That language amounts to a “tacit admission” that NIH reasonably anticipated the work was gain of function, Koblentz said.

Stefano Bertuzzi, CEO of the American Society for Microbiology, conceded that labs should report more often to Congress and that scientists could do a better job allaying public concerns, but stated that the framework is otherwise sufficient. 

Bertuzzi signaled he is concerned that Congress could step in.

Labs taking steps toward greater transparency “helps guard against well intended but sometimes overly prescriptive legislative approaches that could undermine the important work that needs to take place.” 

Gigi Gronvall, senior scholar at the Johns Hopkins Center for Health Security, said that the “breathless hyping of risks” overshadows strong existing biosafety measures, such as U.S. efforts to train maximum containment labs abroad.

Asked which risks have been misunderstood, Gronvall said that “there is a lot of gray” and that the proper expertise is needed to interpret gain-of-function experiments, but did not go into further detail. 

Indeed, some experts called for decreased transparency for controversial research. Colorado State University Biosafety Rebecca Moritz called for limiting the scope of public records requests. U.S. Right to Know has submitted a public information request for records about the university’s research on bat coronaviruses in collaboration with EcoHealth Alliance, the U.S. Department of Defense (DoD) and the Defense Advanced Research Projects Agency.

The documents raise questions about the contagion risks, for example, of shipping of bats and rats infected with dangerous pathogens.

Kanta Subbarao, director of the World Health Organization’s Collaborating Centre for Reference and Research on Influenza, disputed the idea that research that contributes to vaccine development or results from surveillance should be included in the framework. 

Many representatives of the life science and biodefense fields emphasized weighing any regulation against lost opportunities for science. But members of the public who participated in the meeting were much more skeptical of the value of certain gain-of-function work.  

Alina Chan, a molecular biologist at the Broad Institute, said that the public should not be surprised by controversial gain-of-function experiments for the first time in scientific papers, long after the research has been approved and completed. 

Chan called for controversial experiments to be published on preprint servers and the genomes of novel viruses to be deposited into publicly available databases within a year of discovery.

She also called for greater transparency from private “virus hunting” organizations and middlemen between the NIH and labs, an apparent allusion to the EcoHealth Alliance and the Global Virome Project

Kevin Esvelt, a biologist at the Massachusetts Institute of Technology, said creating novel viruses in the lab, combined with the ease of synthesizing viruses from a genome sequence, poses a national security threat.

“More Americans have died of COVID than would perish if a Russian Topol SS-25 thermonuclear warhead were to be detonated in the center of Washington, DC,” said Esvelt. “Pandemic viruses can be more lethal than thermonuclear weapons. That makes them a proliferation concern.”

USRTK asks ODNI to declassify documents about accidents at labs that store dangerous pathogens

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U.S. Right to Know (USRTK) has asked the Office of the Director of National Intelligence (ODNI) to declassify three documents about biosafety lapses occurring in laboratories that store dangerous pathogens.

The mandatory declassification review (MDR) request responds to ODNI’s decision to withhold three classified documents responsive to a Freedom of Information Act request USRTK submitted in August 2020.

The FOIA request “sought finished intelligence produced since January 2015 about the accidental or deliberate release of biological agents, containment failures in biosafety-level (BSL)-2, BSL-3 or BSL-4 research facilities, and other incidents of concern related to dual-use biosafety research in BSL-2, BSL-3 or BSL-4 research facilities in Canada, China, Egypt, France, Germany, India, Iran, Israel, the Netherlands, Russia, former countries of the Soviet Union, South Africa, Taiwan, the United Kingdom, and Thailand.”

ODNI said in its response that it had located three documents, and determined these “must be withheld in their entirety pursuant to FOIA exemptions” regarding the protection of classified materials concerning intelligence methods and sources of national security relevance. ODNI did not describe or characterize the nature of the three documents or their contents, other than that they were responsive to the FOIA request.

In its MDR request, USRTK requested that ODNI release all reasonably segregable nonexempt portions of the three documents.

USRTK believes the public has a right to know what data exists about accidents, leaks and other mishaps at laboratories where pathogens of pandemic potential are stored and modified, and whether any such leaks are implicated in the origins of COVID-19, which has caused the deaths of more than 360,000 Americans.

For more information

U.S. Right to Know is posting documents from our public records requests for our biohazards investigation. See: FOI documents on origins of SARS-CoV-2, hazards of gain-of-function research and biosafety labs.

Background page on U.S. Right to Know’s investigation into the origins of SARS-CoV-2.

Written by Sainath Suryanarayanan