Critics applaud cautiously as US lifts ban on making lethal viruses
20 December 2017
The US government on Tuesday lifted a ban on making lethal viruses, saying the research is necessary to "develop strategies and effective countermeasures against rapidly evolving pathogens that pose a threat to public health''.
A moratorium had been imposed three years ago on funding research that alters germs to make them more lethal. Such work can now proceed, said Dr Francis S Collins, head of the National Institutes of Health, but only if a scientific panel decides that the benefits justify the risks.
Some scientists are eager to pursue these studies because they may show, for example, how bird flu could mutate to more easily infect humans, or could yield clues to making a better vaccine.
Critics say these researchers risk creating a monster germ that could escape the lab and seed a pandemic.
"We have a responsibility to ensure that research with infectious agents is conducted responsibly, and that we consider the potential biosafety and biosecurity risks associated with such research," Collins said in a statement.
The decision brings an end to a moratorium on research involving the influenza virus, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
According to the new guidelines, the pathogen to be modified must pose a serious health threat, and the work must produce knowledge - such as a vaccine - that would benefit humans. Finally, there must be no safer way to do the research.
''We see this as a rigorous policy,'' Dr. Collins said. ''We want to be sure we're doing this right.''
The government put a temporary stop to the research in 2014 to review the practices in handling and storing infectious agents. At the time, Collins said that biosafety and biosecurity risks needed to be "understood better."
The pause came after several incidents involving the mishandling of potentially dangerous pathogens at government laboratories.
There has been a long, fierce debate about projects - known as ''gain of function'' research - intended to make pathogens more deadly or more transmissible.
In 2011, an outcry arose when laboratories in Wisconsin and the Netherlands revealed that they were trying to mutate the lethal H5N1 bird flu in ways that would let it jump easily between ferrets, which are used to model human flu susceptibility.
Tensions rose after the US Centers for Disease Control and Prevention accidentally exposed dozens of workers to anthrax in 2014, and a subsequent investigation detailed other instances in which lab workers did not follow protocol. Around that time, vials of the deadly smallpox virus were found in a cardboard box in an unsecured refrigerator at the National Institutes of Health's campus in Bethesda, Maryland (See: Mishaps with live germ stock force closure of two CDC labs).
In Tuesday's announcement, the institutes said that approved research would take place only if the researcher and institution where the research is being conducted demonstrate the "capacity and commitment to conduct it safely and securely, and have the ability to respond rapidly" should things go wrong.
It also said that the research must be "ethically justifiable" and that any pathogen created, transferred or used in the research "must be reasonably judged to be a credible source of a potential future human pandemic".
There was mixed reaction from critics. Dr Tom Frieden, who was the director of the CDC from 2009 to 2017, applauded Tuesday's decision, telling CNN such studies "help scientists better understand how dangerous organisms work, with the ultimate goal of learning how to stop them."
"There's benefit to be gained from this research, but only if lab safety is a top priority and limited to a small group of highly trained staff," said Frieden, who now serves as president and chief executive of the initiative Resolve to Save Lives.
But Richard H Ebright, a molecular biologist and bioweapons expert at Rutgers University, told the New York Times,''There's less than meets the eye.''
Although he applauded the requirement for review panels, he said he would prefer independent panels to government ones.
He also wanted the rules to cover all such research rather than just government-funded work, as well as clearer minimum safety standards and a mandate that the benefits ''outweigh'' the risks instead of merely ''justifying'' them.
When the moratorium was imposed, it effectively halted 21 projects, Dr Collins said. In the three years since, the NIH created exceptions that funded ten of those projects. Five were flu-related, and five concerned the MERS virus.
That virus is a coronavirus carried by camels that has infected about 2,100 people since it was discovered in 2012, and has killed about a third of them, according to the World Health Organization.