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The NSABB has withdrawn objections to the Nature and Science papers detailing changes leading to H5N1 transmission in a ferret model.

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Hmong ethnic women sell chickens at a Dong Van market in Ha Giang province, Vietnam, Sunday, Feb. 12, 2012. (AP / Na Son Nguyen)

U.S. clears publication path for sensitive bird flu studies

The Canadian Press

Date: Friday Mar. 30, 2012 4:35 PM ET

A panel of U.S. biosecurity experts is withdrawing its objections to the publication of two controversial bird flu studies.

The National Science Advisory Board for Biosecurity says after reviewing revised versions of the studies it is recommending they can be published in full.

The board's recommendation must go to the U.S. government, which will then decide whether to accept or reject it.

If the U.S. government withdraws its objections, the move will draw to a close a controversy that has dragged on since late last fall.

The board voted unanimously to clear for publication a study by Yoshihiro Kawaoka of the University of Wisconsin-Madison.

The committee voted 12 to 6 on the second study, done by Dutch virologist Ron Fouchier.

Read more: http://www.ctv.ca/CTVNews/Health/201203 ... z1qdeI7wmh

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A U.S. biosecurity advisory panel has reversed course and is recommending that the U.S. government allow full publication of two controversial flu studies.

After spending two days reconsidering the two manuscripts, the 23-member National Science Advisory Board for Biosecurity (NSABB) announced today that it now supports publication of the two studies, in press at Science and Nature, that describe how researchers made the H5N1 avian influenza virus more transmissible between mammals, possibly providing a blueprint for starting a flu pandemic.

Late last year, NSABB's 23 voting members unanimously recommended that the two teams withhold key details from the publications, sparking a global controversy. A second panel of experts convened by the World Health Organization came to the opposite conclusion, calling for full publication.


Today's NSABB recommendation goes to the secretary of the Department of Health and Human Services, Kathleen Sebelius. U.S. officials are not obligated to follow NSABB's advice, but it is expected to carry substantial weight.


NSABB's full statement follows:


March 29‐30, 2012 Meeting of the National Science Advisory Board for Biosecurity to Review Revised Manuscripts on Transmissibility of A/H5N1 Influenza Virus




STATEMENT OF THE NSABB

The United States Department of Health and Human Services convened the National Science Advisory Board for Biosecurity (NSABB) on March 29‐30, 2012, to examine two revised manuscripts regarding the transmissibility of A/H5N1 influenza virus (avian flu) in ferrets. Earlier versions of these manuscripts had been submitted for publication in Science and Nature and were reviewed by the Board.

The NSABB is an independent federal advisory committee chartered to provide advice and guidance on the biosecurity oversight of dual use research to the Secretary of the Department of Health and Human Services, the Director of the National Institutes of Health, and all federal entities that conduct, support or have an interest in life sciences research. Dual use research is defined as biological research with legitimate scientific purpose that may be misused to pose a threat to public health and/or national security.

The Board was asked to consider the revised manuscripts from Dr. Ron Fouchier of Erasmus Medical Center and Dr. Yoshihiro Kawaoka of the University of Wisconsin and to recommend whether the information they contain should be communicated and, if so, to what extent. In their evaluation, the Board used analytical tools that it previously developed for considering the risks and benefits associated with the communication of dual use research of concern (available at www.biosecurityboard.gov). After careful deliberation, the NSABB unanimously recommended that this revised Kawaoka manuscript should be communicated in full. The NSABB also recommended, in a 12 to 6 decision, the communication of the data, methods, and conclusions presented in this revised Fouchier manuscript.

As a general principle, the NSABB strongly supports the unrestricted communication of research information unless that information could be directly misused to pose a significant and immediate risk to public health and safety. While the communication of the information in these revised manuscripts still presents dual use concerns, the additional information changed the Board's risk/benefit calculation.

• The data described in the revised manuscripts do not appear to provide information that would immediately enable misuse of the research in ways that would endanger public health or national security.

• New evidence has emerged that underscores the fact that understanding specific mutations may improve international surveillance and public health and safety. Global cooperation, critical for pandemic influenza preparedness efforts, is predicated upon the free sharing of information and was a fundamental principle in evaluating these manuscripts.

The Board's recommendations were informed by the newly released United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern. This policy applies to federally funded life sciences research and will ensure that dual use concerns are addressed during evaluation of ongoing and future research on A/H5N1 influenza virus.

As a part of these deliberations, the Board emphasized the urgent need for the further development of processes for the responsible communication of dual use research of concern. It noted that improving public health and safety will require a sustained global approach to addressing dual use concerns presented by life sciences research while encouraging a robust research enterprise.

The NSABB recommendations from this meeting will be forwarded to the U.S. Government for review and consideration.

http://news.sciencemag.org/scienceinsid ... html?rss=1

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US experts give nod to publish mutant bird flu studies

By Kerry Sheridan (AFP) – 39 minutes ago

WASHINGTON — A panel of US science and security experts on Friday said two papers on a mutant bird flu should be published after all, reversing its earlier decision to withhold key details.

The announcement came after the latest research and revisions to the papers led by a Dutch and a US team of scientists were reviewed by the nongovernmental US National Science Advisory Board for Biosecurity (NSABB).

The US experts had previously opposed publishing the research -- which showed how an engineered H5N1 flu virus could pass easily in the air between ferrets -- over fears it could end up in the wrong hands and unleash a deadly flu pandemic.

"The data described in the revised manuscripts do not appear to provide information that would immediately enable misuse of the research in ways that would endanger public health or national security," said a statement from the NSABB.

After meeting to review the latest details on March 29-30, the experts saw "new evidence has emerged that underscores the fact that understanding specific mutations may improve international surveillance and public health and safety.

"Global cooperation, critical for pandemic influenza preparedness efforts, is predicated upon the free sharing of information and was a fundamental principle in evaluating these manuscripts," it added.

The NSABB faced criticism after it ruled unanimously in December that a pair of US-funded studies, one by a team from Wisconsin and the other led by Netherlands-based scientist Ron Fouchier, should not be printed without heavy edits of key details to prevent the work from being replicated.

A subsequent meeting of flu experts in Geneva came to the opposite conclusion and urged the prestigious journals Science and Nature to print them as planned, but agreed caution was needed and backed a temporary halt to further research.

At the latest NSABB meeting, experts agreed unanimously that the Wisconsin team's research should be published in full, as planned by the British journal Nature.

However the vote on Fouchier's research, slated for publication in the US journal Science, was approved by a vote of 12-6, indicating some lingering doubts among members.

NSABB board member Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota School of Public Health, said last month he was concerned about potential havoc by amateurs.

"I am not personally worried about somebody in a cave somewhere," he said. "I worry about the garage scientist, about the do-your-own scientist, about the person who just wants to see if they can do it."

Meanwhile, Fouchier has insisted that the mutant virus is not as lethal as the public has been led to believe, and urged its publication so that scientists can prepare remedies should such a variant arise in nature.

The new NSABB recommendations will be forwarded to the US government for "review and consideration," the group said in its statement on Friday.

Bird flu is believed to kill more than half the people it infects, making it much more lethal than typical strains of the seasonal virus.

According to the World Health Organization, there have been 573 cases of H5N1 bird flu in humans in 15 countries since 2003, with 58.6 percent of those resulting in death.

http://www.google.com/hostednews/afp/ar ... d7b33.1141

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Federal Board OKs Bird Flu Studies

By Maggie Fox

Updated: March 30, 2012 | 5:42 p.m.
March 30, 2012 | 5:16 p.m.


Balinese health official holds a chicken to be slaughter as bird flu suspect at Jagapati village in Denpasar, Bali, Indonesia, Tuesday, Feb. 10, 2009. Indonesia has been the country hardest hit bybird flu, accounting for nearly half of the disease's worldwide fatalities.



A federal advisory committee that has been debating whether to try to limit publication of two controversial bird flu studies said late on Friday they could safely move forward and wouldn't provide fodder for would-be bioterrorists.

The National Science Advisory Board for Biosecurity had asked researchers in December to hold up two studies that involved tinkering with the H5N1 bird flu virus to try and make it more easily transmitted. The two research teams, one led by Dr. Ron Fouchier of Erasmus Medical Center in the Netherlands and the other by Dr. Yoshihiro Kawaoka of the University of Wisconsin, had agreed to suspend the studies temporarily while the scientific community and governments took a closer look.

The NSABB, which advises the Health and Human Services Department, said the decision was too big for the scientific community to make on its own, comparing it to the 1940s Manhattan Project.

In February, the World Health Organization held a special meeting on the issue.

The scientists, both of whom got funding from the National Institutes of Health, are not bound by the NSABB’s request. But the panel said they provided information that alleviated concerns about the safety of the work. “The Board was asked to consider the revised manuscripts from [Fouchier and Kawaoka] and to recommend whether the information they contain should be communicated and, if so, to what extent,” the board said in a statement.

“After careful deliberation, the NSABB unanimously recommended that this revised Kawaoka manuscript should be communicated in full. The NSABB also recommended, in a 12-to-6 decision, the communication of the data, methods, and conclusions presented in this revised Fouchier manuscript.”

Since it started spreading in 2003, H5N1 bird flu has killed 352 of the 598 people it is known to have infected--a mortality rate of 59 percent. This compares to a 2.5 percent fatality rate for the 1918 flu, which killed tens of millions of people, or 30 percent for smallpox before it was eliminated in 1979. Luckily, H5N1 doesn’t infect people easily, but it spreads rapidly through flocks of chickens, infects ducks with barely a symptom, and appears to be carried by migrating wild birds. All flu viruses mutate, and most flu experts fear it is only a matter of time before H5N1 either evolves or mixes up with another flu virus to make a form that can easily infect people.

Both labs were tinkering with H5N1 to see what it would take to make the virus both easily transmissible and still harmful, to help with preparing for the possibility of a new pandemic.

Bruce Alberts, editor‐in‐chief of the journal Science, which had delayed publishing Fouchier’s paper, expressed relief. “We are pleased by the NSABB’s decision to recommend publication of a revised version of Dr. Fouchier’s article that presents the data, methods, and conclusions in an unredacted form,” Alberts said in a statement.

“Dr. Fouchier’s paper describes genetic changes that allow the virus to be transmitted between ferrets via aerosol or respiratory droplets. The virus, which is already widespread in birds, continues to evolve rapidly in nature. Because the ferret provides a model for human transmissibility, these results underscore the importance of surveillance to determine if the virus is evolving in a direction that raises further concerns for a human pandemic,” he added.

“Making the complete research results available via peer‐reviewed publication in Science will help responsible influenza researchers design antivirals and vaccines to combat outbreaks, as well as make possible improved international surveillance to protect public health and safety.”

Nature said it would publish Kawaoka's paper right away.

"Subject to any outstanding regulatory or legal issues, we intend to proceed with publication as soon as possible," Nature's editor in chief Philip Campbell said in a statement.

Earlier on Friday, the NIH released new rules tightening the drill on such “dual-use” research--studies that can be used both for good and for warfare or terrorism.

They call for tighter scrutiny of U.S. funding of studies involving 15 pathogens, from bird flu to Ebola, anthrax and plague. Dr. Anthony Fauci, director of the U.S. Institute of Allergy and Infectious Diseases, said the rules formalized policies already in effect. “I don’t think it bad at all,” Fauci told National Journal. “I don’t think it is going to interfere with the timing of grants. I don’t think it going to have an impact at all.”

http://www.nationaljournal.com/tech/fed ... s-20120330

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Flu Research Is Safe to Publish, Panel Says

By DENISE GRADY

Published: March 30, 2012

After months of debate and public furor over experiments that made a dangerous flu virus more contagious, a panel of scientific advisers reversed itself on Friday and recommended that details of the research be published in full in scientific journals.

The panel, the National Science Advisory Board for Biosecurity, had originally recommended in December that scientific reports about the research be published only if certain details were withheld, to prevent others from replicating the experiments. The fear was that bioterrorists would use the information to create germ weapons.

There was also concern by some scientists that the virus would leak out of a laboratory by accident and start a pandemic.

The December recommendation was the first time that the biosecurity panel had ever advised keeping details of biological research secret.

In a statement issued on Friday, the board said that the reports had been revised and that the data in them “did not appear to provide information that would immediately enable misuse of the research in ways that would endanger public health or national security.”

In addition, it said, new data has emerged indicating that understanding the precise genetic changes that increase contagiousness in flu viruses could improve scientists’ ability to monitor viruses in the environment and identify those with the most potential danger.

The experiments involve a type of bird flu virus known as H5N1. It does not often infect people, but appears unusually deadly when it does. People almost never transmit the virus to one another, but if the virus were to become transmissible, deadly pandemics could ensue.

The experiments in question studied the virus in ferrets, considered a good model for the way flu viruses affect people. In the course of studying transmissibility, the research teams created a strain of the virus that could spread through the air from one animal to another — something that had not existed before.

The work, paid for by the National Institutes of Health, was done by two separate research teams, at Erasmus Medical Center in Rotterdam, in the Netherlands, and at the University of Wisconsin-Madison.

In January the scientists voluntarily suspended research on the viruses because of the uproar it provoked. The moratorium was to last two months, but the World Health Organization said in February that it would probably be extended for a few more months.

http://www.nytimes.com/2012/03/31/healt ... emc=rss%3f

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Re-Engineered Bird Flu Data Can Be Made Public, U.S. Panel Says

By Alex Wayne - Mar 30, 2012 5:31 PM ET

Research on a more lethal re- engineering of the avian influenza can be made public by the scientists who created it after a review determined no immediate threat from releasing the data, a U.S. biosecurity panel said.

The National Science Advisory Board for Biosecurity recommended unanimously that a revised bird flu study by Yoshihiro Kawaoka of the University of Wisconsin be published “in full.” The board voted 12-6 to recommend publication of “data, methods and conclusions” from a second study, by Ron Fouchier of Erasmus Medical Center in Rotterdam.

The data “do not appear to provide information that would immediately enable misuse of the research in ways that would endanger public health or national security,” the board said today in a statement.

Groups led by Fouchier and Kawaoka engineered the H1N1 virus to be more transmissible among ferrets, mammals whose response to the flu is most like humans. The studies were intended to demonstrate how the virus might be changed to spread rapidly between people, giving scientists and health officials more information in case of a pandemic.

Publication of the studies in Science and Nature has been on hold since December, when the U.S. government asked the journals to censor details of the research so it wouldn’t “fall into the wrong hands,” the editor of Science said. Fouchier and Kawaoka also agreed to suspend their research pending a review.

A World Health Organization panel met in Geneva in February and recommended publication of the studies.

To contact the reporter on this story: Alex Wayne in Washington at awayne3@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
http://www.bloomberg.com/news/2012-03-3 ... -says.html

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Scientific Journals Plan To Publish Contentious Bird Flu Research

by Nell Greenfieldboyce

05:49 pm

March 30, 2012
A government advisory committee has reconsidered its advice to keep certain details of bird flu experiments secret.

Revised versions of manuscripts that describe two recent studies can be openly published, the committee now says. The decision could help end a contentious debate that has raged within the scientific community for months.

In response, the editors of two journals immediately said they planned to publish the research soon.

The editor-in-chief of the journal Nature, Philip Campbell, said in an emailed statement that his journal was delighted at the news. "Subject to any outstanding regulatory or legal issues, we intend to proceed with publication as soon as possible," Campbell said.

The editor-in-chief of the journal Science, Bruce Alberts, said in a statement that his journal "will proceed in an expedient but careful manner" to publish the research in full.

Late last year, the National Science Advisory Board for Biosecurity reviewed two papers describing experiments on bird flu and recommended that science journals not publish the full details. The concern was that the information could reveal how to create a contagious new form of the bird flu virus that could potentially be used as a bioweapon.


More Coverage


Policy On High-Risk Biological Research TightenedMarch 30, 2012


Bird Flu Studies Getting Another Round Of Scrutiny By PanelMarch 26, 2012

U.S. government officials accepted that assessment and began working to set up a secure system for sharing the sensitive information only with scientists who had a legitimate need to know. But officials quickly realized that thorny legal issues were going to make it very difficult to develop such a system for researchers all around the world.

Then, in February, a group convened by the World Health Organization called for full publication of the bird flu studies, saying that widely sharing the information was important for public health efforts to prepare for flu pandemics that might emerge in the future.

Government officials consequently asked the NSABB to take another look at revised versions of the manuscripts, plus additional information. In a two-day meeting that ended today, the panel of scientists and security experts heard from the researchers who did the work and also got a classified briefing from the intelligence community.

The NSABB now says "the data described in the revised manuscripts do not appear to provide information that would immediately enable misuse of the research in ways that would endanger public health or national security."

In addition, the committee cited new evidence that "underscores the fact that understanding specific mutations may improve international surveillance" to detect an emerging flu pandemic.

The vote was unanimous for one of the revised papers, from a group led by flu researcher Yoshihiro Kawaoka at the University of Wisconsin-Madison.

But not everyone on the committee agreed about what to do with a study from the lab of Ron Fouchier of Erasmus Medical Center in the Netherlands. For that revised paper, the vote was 12 to 6 in favor of openly publishing the data, methods, and conclusions.

The committee has no power to enforce its advice, but its views do carry weight. The flu researchers and science journals have voluntarily held off on publication since the NSABB gave its initial recommendations.

Meanwhile, the government is taking steps to try to prevent a controversy like this from arising in the future.

Yesterday officials released a new policy for overseeing biological research that could potentially be used to threaten the public. It calls for screening proposed and ongoing government-funded research projects that involve 15 particularly nasty pathogens and toxins, such as Ebola, anthrax and highly pathogenic bird flu.

If it appears that experiments could yield potentially dangerous information, officials will have to develop a plan to mitigate the risk that the work could be misused. In some cases, the work could be classified.

http://www.npr.org/blogs/health/2012/03 ... u-research

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