The White House today stepped into an ongoing debate about controversial virus experiments with a startling announcement: It is halting all federal funding for so-called gain-of-function (GOF) studies that alter a pathogen to make it more transmissible or deadly so that experts can work out a U.S. government-wide policy for weighing the risks. Federal officials are also asking the handful of researchers doing ongoing work in this area to agree to a voluntary moratorium.
The “pause on funding,” a White House blog states, applies to “any new studies … that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route.” The government also “encourages those currently conducting this type of work—whether federally funded or not—to voluntarily pause their research while risks and benefits are being reassessed.” Research and testing of naturally occurring forms of these pathogens will continue.
An accompanying document describes plans for a two-stage “deliberative process” to determine the risks and benefits of GOF experiments and to develop a U.S. policy for approving new studies. It will begin next week when the National Science Advisory Board for Biosecurity (NSABB), an advisory group that has not met for 2 years, convenes on 22 October to begin designing a study to assess the risks and benefits of GOF research. The National Academies’ National Research Council (NRC) and Institute of Medicine (IOM) will also hold a symposium to discuss the scientific issues, then later review NSABB’s recommendations, which are due within 6 months. “The NRC and IOM have begun selecting an expert committee to oversee this event, which will be held in public, webcast, and archived for the widest possible distribution,” according to a statement from the academies. The White House plan is to have a final policy in place within a year.
The U.S. government is responding to a resurgence in concerns about GOF studies, which have deeply split the scientific community. Three years ago, two separate research teams revealed that they had made a version of the H5N1 avian influenza strain that spread between ferrets. Many scientists worried that if the potent new lab strain were accidentally or deliberately released, it could result in a deadly pandemic. Proponents argued that such studies will help public health researchers detect an impending flu pandemic and prepare vaccines.
After much discussion, a decision to publish the papers, a 1-year voluntary moratorium by researchers on new GOF flu studies, and new U.S. rules, the work resumed last year. But as new papers on humanmade H5N1 and other dangerous flu strains have come out in recent months, concerns have been rekindled—in part because of lab accidents at the U.S. Centers for Disease Control and Prevention that raised questions about safety at U.S. high-containment labs.
A group calling itself the Cambridge Working Group issued a statement in July saying that studies with “potential pandemic pathogens” should be “curtailed” until the risks and benefits could be evaluated; it has garnered hundreds of signatures. Another group of scientists supporting the experiments—they call themselves Scientists for Science—defended the studies as safe but also called for a meeting to discuss the issues.
That discussion will now happen, although today’s announcement took many scientists involved in the issue by surprise.
Harvard University epidemiologist Marc Lipsitch, who co-organized the Cambridge Working Group statement and personally supports a moratorium on GOF flu studies, says he is “very pleased” with the announcement. “I think the deliberative process is exactly what we and also Scientists for Science have called for,” Lipsitch says.
Boston University microbiologist Paul Duprex, a leader of Scientists for Science, says that although he is “not a fan of blanket bans,” there is “precedent” for a pause. He looks forward to “the presentation of hard evidence and the discussion of the data.” Both Lipsitch and Duprex are speaking before NSABB next week.
Also speaking at the meeting will be Michael Osterholm, a former NSABB member and head of the Center for Infectious Disease Research and Policy at the University of Minnesota, Twin Cities. He opposed publication of the earlier H5N1 studies and has long argued that researchers have not undertaken rigorous risk-benefit analyses. “I think it’s a great time to dive into the risk-benefit question,” he told ScienceInsider today. “You’ll never [be able to] fine-tune the calculation down to 1%, but you can reach some reasonable approximation—and do much better than we are doing now.”
“This is major,” says Peter Hale of the Foundation for Vaccine Research in Washington, D.C., who has been campaigning for years for tigher regulation of GOF studies. “Our hope is that investigators who have been conducting these experiments will also implement a pause immediately and stop further work until there is a consensus as to whether this research should be allowed to proceed and, if so, under what conditions.”
Others were less enthusiastic. “The Administration thinks what we need right now is to STOP research on deadly pathogens? WTF?,” tweeted Alan Dove, a science writer and co-host of This Week In Virology, a science podcast and blog.