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Mon March 26, 2012
Bird Flu Studies Getting Another Round Of Scrutiny By Panel
Originally published on Mon March 26, 2012 8:50 am
In June of 2009, a committee met at the University of Wisconsin-Madison to do a routine safety review of proposed research projects.
One of those projects involved genetically modifying flu viruses. And during the review, the committee brought up the idea of "dual-use" research. "Dual use" means legitimate scientific work that's intended to advance science or medicine, but that also might be misused with the intent to do harm.
Now, nearly three years after that meeting, this flu research — along with similar work done in the Netherlands — has the science community in an uproar. Scientists, security experts, flu virologists and others are arguing over whether the details of experiments with lab-altered forms of bird flu can be made public, or whether that would amount to publishing the recipe for a superflu that could be used as a bioweapon.
This week, a panel of experts that advises the government about dual use issues, called the National Science Advisory Board for Biosecurity, is having a closed-door meeting to once again look at unpublished manuscripts describing the completed experiments. Their deliberations will include a classified briefing from the intelligence community.
The whole debate has had some people asking why these questions are being asked after-the-fact, instead of before scientists did this work, which was funded by the National Institutes of Health as part of an effort to better understand how influenza viruses in animals can mutate and cause human pandemics.
But it looks like the safety committee at the University of Wisconsin-Madison actually did recognize the work's dual use potential.
"In the meeting minutes it does say that there was a dual use discussion," says Rebecca Moritz, a research compliance specialist at the University of Wisconsin-Madison's biological safety office. "I don't know the specifics of that discussion but there was one."
The June 3, 2009 minutes of the university's Institutional Biosafety Committee (IBC) describe a review of the "Genetic Engineering of Influenza Viruses" protocol submitted by virologist Yoshihiro Kawaoka.
In addition to describing lab safety measures that the committee assessed, the minutes state: "The dual-use organism concept and the ethical responsibilities of the IBC were discussed."
Susan West, a University of Wisconsin-Madison microbiologist who chairs the IBC now, was at that meeting. West says she can't recall exactly what was discussed in terms of dual use but thinks they did consider that the flu research probably "would come under that category."
"But we did not see that there were any safety issues associated with doing it with the containment that's present on campus," West says.
In an email, Kawaoka told NPR that he was not present at the IBC meeting. "I heard that dual use was mentioned," he wrote.
"No one other than the IBC raised issues regarding dual use since our NIH grant was approved, and the next level of the oversight is the IBC," he added.
He wrote that it "was not a complete surprise" for him that his manuscript describing the work was referred to the NSABB to get advice on what to do after he submitted it to a science journal for publication
"Most biological research has dual-use potential," Kawaoka noted in the email. "However, to critically evaluate the benefits and risks, the findings and their significance — both as research advances and applications for misuse — need to be clear to those making decisions about dual use."
The U. S. government currently does not require institutional biosafety committees to consider the dual use question. These local panels review lab procedures to ensure safety. They are not tasked with asking whether an experiment might produce information that might be dangerous in the wrong hands.
"They had no requirement or obligation to report or to share their concerns if they concluded in the end that the concerns were worthy of further pursuit," says Ruth Faden, a bioethicist at Johns Hopkins University.
Faden served on an influential National Academy of Sciences committee that issued a report on dual-use issues in 2004. It recommended that the government set up a mandatory oversight system. Under its plan, local biosafety committees would be required to screen research to identify projects with dual use potential. For projects of potential concern, an additional review at the national level would determine whether and how to let the research go forward.
But so far, the government hasn't set up any system like that. "In the absence of such a structure, people are going to continue to flounder, and not know what they ought to do," says Faden.
She says the concept of dual use got a lot of attention even before this bird flu controversy. But mere awareness of the concept of dual use doesn't mean scientists, institutions, and funding agencies understand what it is that they should do in any given situation.
"This is not a problem any one person can solve," says Faden. "It's hard to ask people to do the responsible thing if they don't have an environmental system that supports them knowing what is the right thing is to do and then being able to do it."
The other controversial bird flu experiment funded by the NIH took place in the Netherlands. Like the U. S., that country also has no formal system to screen for dual use.
In 2007, however, the Royal Netherlands Academy of Arts and Sciences did issue a Code of Conduct for Biosecurity, to help scientists think about this issue.
One of the advisers who helped develop that code was Ron Fouchier, a Dutch virologist at Erasmus Medical Center whose lab later did the bird flu experiment.
An English version of the code calls for researchers and institutions to "screen for possible dual-use aspects during the application and assessment procedure and during the execution of research projects" and "weigh the anticipated results against the risks of the research if possible dual-use aspects are identified."
Fouchier did not respond to an emailed request for comment on whether such a screening was done and, if so, what the conclusion was.
Koos van der Bruggen is an expert on biosecurity and dual-use research in the Netherlands, and he was secretary of the working group that wrote this code. By email, he said: "I am convinced that the researchers have acted in a way that matches the Code of Conduct. I think that the Code could not have prevented this from happening. But let me state that the Code was not developed for such a direct intervention."
He said the academy knew that a code of conduct was not a panacea for the problems of biosecurity and that the main aim of the code was to simply raise awareness of dual use issues. And however this debate over what to do about lab-altered bird flu ends, he added, "awareness raising surely is one of the consequences."
DAVID GREENE, HOST:
Later this week there will be a closed-door meeting at the National Institutes of Health. On the agenda, controversial bird flu experiments. Scientists altered the bird flu virus in a way that might make it capable of spreading between people, and there's currently a huge fight over whether the details of this work should be kept secret because of fears it could provide a recipe for a biological weapon.
One big question hovering over the controversy is why didn't anyone tackle these issues before the scientists did their experiments? Well, NPR's Nell Greenfieldboyce reports that it looks like some people actually did.
NELL GREENFIELDBOYCE, BYLINE: It is not news that biology can have a dark side. Ever since 9/11 and the anthrax attacks, biologists have talked about the dual-use dilemma, the idea that legitimate research might have the potential to cause harm in the wrong hands.
Take the recent bird flu experiments. Scientists wanted to understand if a flu virus currently out there in birds could mutate and start to spread between people. The researchers discovered that certain genetic tweaks did make the virus spread through the coughs and sneezes of ferrets, the lab's stand-in for people.
And when word of this got out last year, it caused an uproar. Here's Tom Inglesby with the Center for Biosecurity of the University of Pittsburg Medical Center last November.
TOM INGLESBY: People should not be in the business of making viruses more contagious than they already are and showing others how to copy that experimental work.
GREENFIELDBOYCE: Since then, a government advisory committee said not to publish the full details of the work. Researchers declared a moratorium, the World Health Organization hastily arranged an international conference. This week, government advisors are again being convened by the NIH. Their meeting will feature a classified briefing from the intelligence community. No one knows what will happen next.
So how did we get here? Could this controversy have been predicted? I called the University of Wisconsin - Madison, which did one of the two flu studies that have raised concerns. Rebecca Moritz works at its biological safety office. She said, before the research was done, it got routine safety reviews by something called the Institutional Biosafety Committee, or IBC. And she said:
REBECCA MORTIZ: In the meeting minutes, it does say that there was a dual-use discussion. I don't know the specifics of that discussion, but there was one.
GREENFIELDBOYCE: It happened in June of 2009. Susan West is a microbiologist who currently chairs the IBC. She was at the meeting when dual-use came up in the context of the flu research.
SUSAN WEST: I don't remember the exact things. I think we did consider that it was probably - would come under that category, but we did not see that there were any safety issues associated with doing it with the containment that's present on campus.
GREENFIELDBOYCE: And that's really what you guys are supposed to be looking at, right, basically...
GREENFIELDBOYCE: ...is this research, can it be safety done under the described conditions?
GREENFIELDBOYCE: The researcher there who went on to do those experiments is Yoshihiro Kawaoka. In an email, he told NPR he didn't attend this IBC meeting, but heard that dual-use was mentioned. He said, quote, "No one other than the IBC raised issues regarding dual-use since our NIH grant was approved, and the next level of the oversight is the IBC." Unquote.
But university IBCs aren't actually required to consider the dual-use question as part of their safety review. In fact, the government currently has no formal mechanism to screen proposed experiments and identify those that might produce dangerous information.
RUTH FADEN: In the absence of such a structure, people are going to continue to flounder, and not know what they ought to do.
GREENFIELDBOYCE: Ruth Faden is a bioethicist at Johns Hopkins University. She serves on an influential panel that issued a report on the dual-use problem in 2004. It recommended that the government set up a mandatory screening system and give higher risk proposals special oversight. Since then, there's been lots of talk about dual-use and efforts to educate scientists. But Faden says that's not enough.
FADEN: This is not a problem any one person can solve. It's hard to ask people to do the responsible thing if they don't have an environmental system that supports them - knowing what is the right thing and then being able to do it.
GREENFIELDBOYCE: The other controversial bird flu experiment funded by the NIH took place in the Netherlands. That country also has no formal system to screen for dual use. But in 2007, it's National Academy of Sciences did issue a code of conduct for biosecurity. The goal was to help scientists become more aware of these issues. One of the advisors who helped develop that code was Ron Fouchier, the Dutch virologist whose lab later made the mutant form of bird flu.
Nell Greenfieldboyce, NPR News. Transcript provided by NPR, Copyright NPR.