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 They are scrutinizing the actions of the nation's leading
biomedical research institute, the National Institutes of Health,
which in 2004 established a panel of independent advisors to make
recommendations about research on pathogens that could be used as
biological weapons.
Some private sector biosafety experts say NIH has marginalized the
board to prevent it from interfering in research that NIH funds.
In the last two years, members of the National Science Advisory
Board for Biosecurity (NSABB) found their responsibilities reduced
and their meetings canceled, and nearly a dozen were abruptly
dismissed, according to seven current and former board members and a
Reuters review of agency documents.
A spokesman for the Department of Health and Human Services (HHS),
NIH’s parent agency, said the changes reflected the agency's
assessment of what it needed from the board and dismissed the
suggestion that NIH had marginalized the advisers.
A lack of real oversight could pose a major risk to the public at
large, as hundreds of laboratories across the country work with
deadly pathogens ranging from bird flu to Ebola without any
assessment of the possible risk.
"If there were an accidental release of pathogens, we could be
talking about a substantial percentage of the world population
succumbing to it," said biologist Richard Roberts, who shared the
1993 Nobel Prize in medicine and is now the chief scientific officer
at New England Biolabs.
"SERIOUS QUESTIONS"
In a July 28 letter to NIH Director Dr Francis Collins, Republican
lawmakers said the role of the NSABB "has assumed even greater
important and visibility" in light of the recent anthrax and bird
flu breaches at the U.S. Centers for Disease Control and Prevention,
NIH's sister agency.
The recent changes to the NSABB "raise serious questions about the
rationale and motives behind the dismissals of the panel members,"
wrote the lawmakers, members of the House of Representatives Energy
and Commerce Committee, which is also investigating the CDC mishaps.
They asked NIH to come back to them by Friday. NIH spokeswoman
Renate Myles said it was preparing a response.
In June, a CDC lab working with anthrax sent samples of that
bacteria to labs that lacked the safety precautions required to
handle the microbe, potentially exposing scores of workers.
Investigators examining the anthrax breach discovered that in March
a different CDC lab had sent a dangerous form of bird flu to an
agriculture lab that had requested a benign form, again putting
workers in danger.
As part of its plan to address the lapses, CDC last month announced
the formation of a panel of outside experts to advise it on lab
safety and will provide staff and budget and determine when the
panel meets. CDC spokesman Tom Skinner said the advisors "will have
the ability to work autonomously."
But biosafety experts said the NSABB experience showed that approach
was inherently conflicted.
"Organizations are notoriously bad at policing themselves," said
biodefense expert Greg Koblentz of George Mason University. Ideally,
an advisory body should not depend on or report to the organization
it is overseeing, he said.
ANTHRAX ATTACKS
After anthrax was mailed to members of Congress and media outlets in
2001, the United States embarked on a massive biodefense build-up,
more than tripling the number of laboratories studying dangerous
pathogens to 1,500. Three years later, NIH created the NSABB
to recommend and develop guidelines for research that could have the
unintended consequence of creating bioweapons.
In recent years, however, NIH narrowed the board's responsibilities
and did not follow through on members' requests to study hot-button
issues, according to a former member of the board. Last month, it
dismissed 11 of 23 members without warning, saying their services
were no longer needed.
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"There can be no serious doubt that the intent was to eliminate
review of gain-of-function research on potential pandemic
pathogens," said biologist Richard Ebright, a biosecurity expert at
Rutgers University, who is not a panel member but was tipped off to
the changes by a government official in July.
In gain-of-function research, scientists alter naturally occurring
pathogens to make them more contagious, among other enhancements
HHS did not provide a rationale for the changes but said the
government often changes the membership and duties of advisory
boards. It "assesses what advice it needs from the board and then
considers whether to modify the charter accordingly," said the HHS
spokesman, who did not address the allegation that the government is
trying to muffle potential criticism.
AVIAN FLU
The board's most high-profile action came in 2011, when it
recommended not publishing details of two NIH-funded studies
identifying genetic changes that make the deadly bird flu virus more
contagious.
Critics viewed that as a radical step akin to censorship, but panel
members feared that publishing the full findings would offer a
recipe for bioweapons, a stance that some academic scientists agreed
with.
The World Health Organization pressed the panel to withdraw its
objections, worried that if the research were not published
countries would be denied crucial information to detect dangerous
new forms of avian flu. The NSABB did so, but got the authors to
omit key details that could allow their work to be copied by
malicious actors.
"That set an example for the publication of other sensitive
research," said Dr Arturo Casadevall of Albert Einstein College of
Medicine and an NSABB member until last month. "The world was
different after that, as sensitive papers began to be scrutinized
more carefully" for biosecurity issues.
Since then, NIH has called only one NSABB meeting, in November 2012,
though its charter requires twice-yearly meetings.
NIH had scheduled three telephone meetings with some board members
who wanted to discuss how to calculate whether the benefits of
gain-of-function experiments - saving lives by creating a new flu
vaccine - exceeded their risks: manmade microbes escaping. It
canceled each of the three at the last minute without giving any
reasons, said dismissed NSABB member Michael Osterholm of the
University of Minnesota.
The absence of a rigorous cost-benefit analysis is "one of the
biggest deficits we have, not knowing if the risk of an experiment
exceeds its potential benefits," Osterholm said.
NIH said the board had not met in two years because it was not
needed, but did not comment on the canceled telephone meetings.
(Additional reporting by David Morgan,; Editing by Michele Gershberg
and Ross Colvin)
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