Biosafety-level-4 labs work on extremely dangerous pathogens.
In a long-awaited move, federal officials have lifted a moratorium on funding research aimed at making deadly viruses even more dangerous.
Scientists involved in the work argue that it is needed to get one step ahead of the threat posed by naturally emerging viruses that could trigger a disease pandemic. Critics worry that lapses in lab safety could release the very threats that scientists are trying to counter.
The new policy, released on Tuesday, leaves unanswered one key question: If research on a souped-up virus provides a blueprint to create a lethal bioweapon, how should that information be controlled?
The rules apply to any pathogen that has the potential to cause a disease pandemic. Scientists who request federal dollars to enhance a pathogen’s ability to spread or kill will now face a new layer of review organized by the Department of Health and Human Services to decide if the benefits outweigh the risks.
They will have to show there are “no feasible, equally efficacious alternative methods to address the same question.”
The policy ends a moratorium on so-called gain-of-function research imposed in October 2014, which halted efforts to make more dangerous versions of the viruses that cause flu, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS). It applies to these viruses, plus other pathogens that have the potential to kill thousands, if not millions, of people worldwide — including Ebola.
The moratorium stalled more than 20 research projects, although about half were later given exemptions that allowed them to go ahead. Those include efforts to create a version of MERS that would more readily infect mice, by deliberately passing the virus from animal to animal many times over.
That was needed to create an animal model in which to test new drugs and vaccines, and was quickly freed up: Stanley Perlman, a microbiologist at the University of Iowa, told BuzzFeed News that he got an exemption from the moratorium in January 2015.
But other projects remained blocked, including controversial efforts to alter bird flu viruses to understand the genetic changes that may make it easier for them to infect people. Supporters of this research argue that it’s necessary to understand the threat posed by natural viral mutation.
“I worry about the future of this work if we are not moving quickly,” Gigi Kwik Gronvall of the Johns Hopkins Center for Health Security told BuzzFeed News.
Still, critics question whether the benefits outweigh the possibility — however unlikely — of an accidental release of a virus that could kill on a huge scale. “There is a small subset of science where, if you mess up, you jeopardize large, large numbers of people,” Marc Lipsitch, an epidemiologist at the Harvard T.H. Chan School of Public Health, told BuzzFeed News.
Then there is the question of how to control access to the data that could provide the recipe for a deadly bioweapon. Unlike nuclear physicists, who for decades have accepted that some of their work must be classified, biologists are used to publishing their results in scientific journals without restraint.
The new policy says that there should be “responsible communication” of research results, but gives no details.
“What in the hell does that mean?” asked Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “The lack of discussion about this, to me, is the real weakness.”