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Updated: U.S. halts funding for new risky virus studies, calls for voluntary
moratorium


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Jocelyn is a staff writer for Sciencemagazine.

 
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Jocelyn

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David is a Deputy News Editor specializing in coverage of science policy,
energy and the environment.

 
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By 

 <http://news.sciencemag.org/author/jocelyn-kaiser> Jocelyn Kaiser
<http://news.sciencemag.org/author/david-malakoff> David Malakoff 

17 October 2014 5:45 pm

The White House today stepped into an ongoing debate about controversial
virus experiments with
<http://www.whitehouse.gov/blog/2014/10/17/doing-diligence-assess-risks-and-
benefits-life-sciences-gain-function-research> 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.

 <http://www.phe.gov/s3/dualuse/Documents/gain-of-function.pdf> 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 meet 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 the
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
<http://www.sciencemag.org/site/special/h5n1/index.xhtml> 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 man-made H5N1 and other
dangerous flu strains have come out in recent months, concerns have been
rekindled—in part because of
<http://news.sciencemag.org/biology/2014/07/lab-incidents-lead-safety-crackd
own-cdc> 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
<http://www.cambridgeworkinggroup.org/> 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 while 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 the NSABB next week.

Also speaking at the meeting will be Mike 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, 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 cohost of This Week In Virology, a science podcast and
blog.

Posted in  <http://news.sciencemag.org/category/biology> Biology,
<http://news.sciencemag.org/category/policy> Policy

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