A moratorium on certain risky virology studies imposed by the U.S. government last Friday has gone too far, a number of researchers said today. At a meeting at which experts were tasked with hashing out the risks and benefits of these experiments, the opening session instead was dominated by a litany of concerns that research important to public health is being curtailed.
Announced by federal officials on 17 October, the policy halts new federal funding for so-called gain-of-function (GOF) studies that make a pathogen more transmissible in mammals or more pathogenic. It was sparked by ongoing worries about experiments in which researchers modify H5N1 bird flu and other deadly avian strains to learn what mutations might help them to spread among humans. But the so-called pause also applies to GOF work on any influenza strain and two coronaviruses, MERS and SARS. The idea is to provide a year for experts to work out a U.S. government-wide policy for reviewing GOF studies. Researchers who are already funded or have non-U.S. support are encouraged to join a voluntary moratorium.
Andrew Hebbeler, assistant director for biological and chemical threats in the White House Office of Science and Technology Policy (OSTP), explained at a meeting today of the National Science Advisory Board for Biosecurity (NSABB) that the policy is a response to several recent biosafety lapses at federal labs involving mishandled samples of anthrax, H5N1, and smallpox. Although GOF actually encompasses "a huge swath of life sciences research,” he said, officials decided to focus only on influenza, MERS, and SARS because they are can be transmitted through the air and have the potential to spark a pandemic. OSTP told ScienceInsider that about two dozen studies funded by the National Institutes of Health (NIH) are affected; the pause also halts some studies at the U.S. Department of Agriculture.
But the moratorium seems to be sweeping up even routine surveillance work, meeting participants said. Stacey Schultz-Cherry of St. Jude Children's Research Hospital in Memphis, Tennessee, who is deputy director of a World Health Organization influenza surveillance center, says her group was told to put portions of its contract work for NIH on hold. That includes tracking the myriad flu strains circulating globally each year in animals and using the data to help develop candidate vaccine viruses.
Schultz-Cherry defended the work of University of Wisconsin, Madison, virologist Yoshihiro Kawaoka, also at the meeting, and others who did the controversial H5N1 studies. Such GOF studies are "crucial" for the selection of each year's candidate vaccine viruses because they help WHO identify the riskiest strains in the wild, Schultz-Cherry said. An industry scientist, Bill Sheridan of BioCryst Pharmaceuticals Inc., which is headquartered in Durham, North Carolina, cautioned that new flu drugs must be tested on wild strains to look for resistance, which is one way of enhancing a virus. If such GOF work was halted, "we won't be able to develop any antiviral drugs," Sheridan said.
Researchers who study MERS, the virus now spreading from camels to people in the Middle East, are also concerned. Kanta Subbarao of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, said her group has had to stop its efforts to adapt the MERS virus to mice to develop an animal model for the disease. "I have concerns about whether that's the wisest thing to do in the face of an ongoing epidemic," Subbarao said.
Critics of GOF studies admitted the moratorium may have gone too far, but defended the concept. Biosecurity expert Thomas Inglesby of the UPMC Center for Health Security in Baltimore, Maryland, rebutted the argument that GOF is too broad and vague a term. He argued that nobody would support an experiment that attempted to make HIV or Ebola transmissible by air. "There are examples of lines we wouldn’t cross," Inglesby said.
NSABB Chair Samuel Stanley, president of Stony Brook University in New York, said he expects the board to issue a statement to OSTP asking that it move quickly to clarify its GOF definition and convey that information to NIH. Hebbeler noted that exemptions are already allowed for work crucial to public health, but conceded that it will take time for investigators to find out from their program officer at NIH whether they fall in that category.
The meeting's main purpose was not to discuss the moratorium, but to begin advising the government on developing a policy for assessing the risks and benefits of GOF studies and approving such work. The process will involve commissioning outside firms to conduct several "formal" risk assessments. The idea isn't to assess specific projects, but to provide reviews of "types of experiments" as input for the NSABB's recommendations, said NIH Associate Director for Biosecurity and Biosafety Policy Amy Patterson. Harvard University epidemiologist Marc Lipsitch, among others, has pushed for assessments that would weigh benefits against the number of people who could die in a potential humanmade flu pandemic.
At least one scientist expressed skepticism about how such a company risk assessment will be received. Arturo Casadevall of the Albert Einstein College of Medicine in the Bronx, New York, who has concerns about some GOF studies but opposes the moratorium, said: "No number that they're going to come out with is going to settle this debate." But he said the analyses will nevertheless contribute to the discussion. The next step in the deliberations will be a meeting on 15 and 16 December hosted by the National Research Council and the Institute of Medicine.
*Clarification, 23 October, 4:32 p.m.: This item has been modified to clarify the effects of the funding pause on the WHO center at St. Jude Children’s Research Hospital.