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US rollback of experiment oversight likely dangerous

Sharon Begley

14 Aug 2014

By Sharon Begley
As US lawmakers investigate the anthrax and bird flu breaches at a federal laboratory, they have begun to question whether outside oversight of research using dangerous microbes is as independent as federal agencies claim.
They are scrutinising 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 marginalised 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 cancelled, 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 marginalised 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.
In a July 28 letter to NIH Director Dr Francis Collins, Republican lawmakers said the role of the NSABB “has assumed even greater importance and visibility” in light of the recent anthrax and bird flu breaches at the US 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 tomorrow. 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. “Organisations 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 organisation it is overseeing, he said.
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.
Following the dismissals, a biosafety expert told Reuters that in 2010 NIH also eliminated the board’s responsibilities for reviewing specific experiments. None of the seven current or former board members contacted by Reuters had been informed of the change at the time or since. A Reuters review of the board’s charter confirmed the changes.
“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.
REUTERS

By Sharon Begley
As US lawmakers investigate the anthrax and bird flu breaches at a federal laboratory, they have begun to question whether outside oversight of research using dangerous microbes is as independent as federal agencies claim.
They are scrutinising 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 marginalised 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 cancelled, 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 marginalised 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.
In a July 28 letter to NIH Director Dr Francis Collins, Republican lawmakers said the role of the NSABB “has assumed even greater importance and visibility” in light of the recent anthrax and bird flu breaches at the US 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 tomorrow. 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. “Organisations 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 organisation it is overseeing, he said.
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.
Following the dismissals, a biosafety expert told Reuters that in 2010 NIH also eliminated the board’s responsibilities for reviewing specific experiments. None of the seven current or former board members contacted by Reuters had been informed of the change at the time or since. A Reuters review of the board’s charter confirmed the changes.
“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.
REUTERS