An effective ban on virus experiments that make them more dangerous than natural strains could be lifted in the US if senior experts reach an agreement on strict new measures to oversee the work this week. Scientists, public health officials, and representatives from the White House and the Department of Homeland Security will meet in Washington DC to thrash out fresh rules to govern the studies, the riskiest of which have the potential to unleash a global pandemic.
US government security advisers will call for the introduction of a high-level committee to approve studies that have the potential to make germs which are highly transmissible and virulent, and likely to be resistant to vaccines and other medicines.
The panel could refuse funding if the benefits of a study are not considered important enough to outweigh the risks to public health; if the results could be obtained in a safer way; or if the researchers have not demonstrated an ability to do the work safely and securely.
But others want to see more substantial restrictions imposed on the studies that pose the most danger. Some researchers are pushing for an outright ban on certain experiments, and for a tight limit on
the number of laboratories that are allowed to perform the riskiest work.In 2012, two separate teams of researchers made strains of H5N1 bird flu which could spread rapidly among ferrets, the animals often used as human surrogates in flu research. They argued that the work could improve surveillance for dangerous new strains, but critics raised fears that if the viruses escaped, they might spark a devastating pandemic.
With the scientific community divided over the issue, the White House announced 18 months ago a freeze on all public funding for work that could boost the function of influenza, and the coronaviruses, Sars and Mers. The pause allowed for a “deliberative process” to work out the risks and benefits of so-called gain-of-function studies, and to draw up policies for approving new research.
Paul Duprex, professor of microbiology at Boston University, and leader of a group called Scientists for Science said that gain-of-function studies can not only be done safely, but are essential for understanding diseases and developing preventions and treatments. The risks of the research had been “blown out of all proportion,” he said.
“People have worked with dangerous viruses for a very, very long time and risk is something we manage. The reality is that the people who are most at risk are the ones working with these viruses. And self-preservation is very powerful. Whether I’m sitting in front of an Ebola virus or a measles virus, I don’t want to die,” he said.
He added that the US could not return to “business as usual” after the pause in research, but warned that a heavy-handed oversight panel could slow down discoveries and ultimately drive research elsewhere. He said, “My suggestion would be for an oversight committee that is lean, functional and responsive. If another layer of bureaucracy is required, it cannot be seen as either a blocking tool, or a rubber stamping tool.”
The two-day meeting, convened by the US National Academy of Sciences, will be the last to feed into the final recommendations that the US National Science Advisory Board for Biosecurity will submit to the White House for approval later this year.
Marc Lipsitch, professor of epidemiology at Harvard School of Public Health, heads up the Cambridge Working Group, which has campaigned for tougher restrictions on gain-of-function studies. He claims that the benefits of the virus experiements have been “very strongly exaggerated”. Meanwhile, high profile incidents in which live anthrax and potent strains of bird flu were sent out of US government laboratories by mistake have demonstrated that accidents can happen even at gold standard facilities.
Lipsitch has drawn up a series of proposals that aim to make the riskiest virus experiments – a small subset of all gain-of-function studies – safer. They range from requiring sign-off from the head of the National Institutes of Health, the main US public funder; clear red lines prohibiting public funds for certain studies on very dangerous organisms; and a national and international agreement to confine the most risky gain-of-function studies to a small number of labs with exceptional safety and security records. The panel that approves funding must, he said, be independent of the scientists proposing the work, and their potential funders.
Filippa Lentzos, a senior research fellow at King’s College London, has asked the meeting to consider a ban on some experiments. “There will definitely be cases where the risks outweigh the benefits, and there are some experiments which simply should not be done. An example would be making Ebola airborne. There needs to be recognition that certain experiments should not be done,” she said.
“This is bigger than whether or not the work is safe to do,” she added. “These kinds of experiments incorporate wider social, ethical, environmental and security risks that the scientists reviewing the safety aspects are simply not experts in.”
