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Resulting from concerns about recent research on avian influenza, scientists working on transmission of the H5N1 strain have agreed to halt this area of research for 60 days to allow time for international discussion.

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Ron A. M. Fouchier,1* Adolfo García-Sastre,2 Yoshihiro Kawaoka,3 Wendy S. Barclay,4 Nicole M. Bouvier,5 Ian H. Brown,6
Ilaria Capua,7 Hualan Chen,8 Richard W. Compans,9 Robert B. Couch,10 Nancy J. Cox,11 Peter C. Doherty,12 Ruben O. Donis,13
Heinz Feldmann,14 Yi Guan,15 Jaqueline Katz,16 H. D. Klenk,17 Gary Kobinger,18 Jinhua Liu,19 Xiufan Liu,20 Anice Lowen,21
Thomas C. Mettenleiter,22 Albert D. M. E. Osterhaus,23 Peter Palese,24 J. S. Malik Peiris,25 Daniel R. Perez,26 Jürgen A. Richt,27
Stacey Schultz-Cherry,28 John Steel,29 Kanta Subbarao,30 David E. Swayne,31 Toru Takimoto,32 Masato Tashiro,33 Jeffery K.
Taubenberger,34 Paul G. Thomas,35 Ralph A. Tripp,36 Terrence M. Tumpey,37 Richard J. Webby ,38 Robert G. Webster39
1Department of Virology, Erasmus MC, 3000CA Rotterdam, 3015GE Rotterdam, Netherlands. 2Department of Microbiology,
Mount Sinai School of Medicine, New York, NY 10029, USA. 3Department of Pathobiological Sciences, School of Veterinary
Medicine, University of Wisconsin-Madison, Madison, WI 53711, USA. 4Department of Medicine, Imperial College, London,
UK. 5Division of Infectious Diseases and Department of Microbiology, Mount Sinai School of Medicine, New York, NY 10029,
USA. 6Virology Department, Animal Health and Veterinary Laboratories Agency, Addlestone, KT15, UK. 7Istituto
Zooprofilattico Sperimentale delle Venezie, 35020, Padova, Italy. 8Harbin Veterinary Research Institute, CAAS, Harbin 150001,
China. 9Influenza Pathogenesis and Immunology Research Center, Emory University, School of Medicine, Atlanta, GA 30322,
USA. 10Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX 77030, USA. 11Centers
for Disease Control and Prevention, Influenza Division, Atlanta, GA 30333, USA. 12Department of Immunology, St. Jude
Children's Research Hospital, Memphis TN 38105, USA. 13Molecular Virology and Vaccines Branch, Influenza Division,
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. 14Laboratory of Virology, National Institute of Allergy
and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA. 15State Key
Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Hong Kong SAR. 16Immunology and Pathogenesis
Branch, Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. 17Institut für Virologie,
35043 Marburg, Germany. 18National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba R3E
3R2, Canada. 19Department of Preventative Veterinary Medicine, China Agricultural University, Beijing, China. 20Animal
Infectious Disease Laboratory, School of Veterinary Medicine, Yangzhou University, Yangzhou, Jiangsu 225009, China.
21Department of Microbiology and Immunology, Emory University School of Medicine, Atlanta, GA 30322, USA. 22Friedrich-
Loeffler-Institut, D-17493 Greifswald-Insel Riems, Germany. 23Department of Virology, Erasmus MC, Rotterdam, Netherlands.
24Department of Microbiology, Mount Sinai School of Medicine, New York, NY 10029-6574, USA. 25Department of
Microbiology and HKU-Pasteur Research Centre, The University of Hong Kong, Pokfulam, Hong Kong SAR. 26Department of
Veterinary Medicine, University of Maryland, College Park, College Park, MD 20742, USA. 27College of Veterinary Medicine,
Kansas State University, Manhattan, KS 66506, USA. 28Department of Infectious Diseases, St. Jude Children's Research
Hospital, Memphis, TN 38105, USA. 29Department of Microbiology and Immunology, Emory University, School of Medicine,
Atlanta, GA 30322, USA. 30Emerging Respiratory Viruses Section, Laboratory of Infectious Diseases, National Institute of
Allergy and Imfectious Diseases, National Institutes of Health, Bethesda, MD 20892-3203, USA. 31Southeast Poultry Research
Laboratory, USDA/Agricultural Research Service, Athens, GA 30605, USA. 32Department of Microbiology and Immunology,
University of Rochester Medical Center, Rochester, NY 14642, USA. 33National Institute of Infectious Diseases, Influenza
Virus Research Center, Tokyo, 208-001, Japan. 34Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases,
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892-3203 USA.
35Department of Immunology, St. Jude Children's Research Hospital, Memphis, TN 38105-3678, USA. 36Department of
Infectious Diseases, College of Veterinary Medicine, University of Georgia, Athens, GA 30602, USA. 37Influenza Division,
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. 38Department of Infectious Diseases, St. Jude Children's
Research Hospital, Memphis, TN 38105-3678, USA. 39Division of Virology, Department of Infectious Diseases, St. Jude
Children's Research Hospital, Memphis, TN 38105, USA.

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To provide time for these discussions, we have agreed on a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals.
In addition, no experiments with live H5N1 or H5 HA reassortant viruses already shown to be transmissible in ferrets will be conducted during this time. We will continue to assess the transmissibility of H5N1 influenza viruses that
emerge in nature and pose a continuing threat to human health.

Published online 20 January 2012;
10.1126/science.1219412
Include this information when citing this paper.
Comment on this article at http://scim.ag/zr4XKx .

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International scientists on Friday agreed to a temporary two-month halt to controversial research on a bird flu virus that may be easily passed among humans, citing global health concerns.

Two separate teams of researchers, one in the Netherlands and the other in the United States, found ways late last year to engineer the H5N1 virus so that it was transmitted among mammals, something that has previously been rare.

The breakthrough raised alarm the method could fall into the wrong hands and unleash a massive flu pandemic that could cost millions of lives, and a US advisory panel in December urged that key details should remain unpublished.

"Resulting from concerns about recent research on avian influenza, scientists working on transmission of the H5N1 strain have agreed to halt this area of research for 60 days to allow time for international discussion," said the letter from the researchers, published by the journals Science and Nature.

"We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks," it added.

"We propose to do so in an international forum in which the scientific community comes together to discuss and debate these issues."

The US journal Science and the British magazine Nature have been working with researchers on edits to the manuscripts but have not said when or if they would eventually be published.

Until now, bird flu has been rare in humans, but particularly fatal in those who do get sick. H5N1 first infected humans in 1997 and has killed more than one in every two people that it infected, for a total of 350 deaths.

The concern is the virus could mutate and mimic past pandemic flu outbreaks such as the "Spanish flu" of 1918-1919 which killed 50 million people, and outbreaks in 1957 and 1968 that killed three million.

Shortly after the research came to light, the US National Science Advisory Board for Biosecurity, a non-governmental panel of 23 experts, urged the two leading scientific journals to edit out key details.

"The US government is the one that paid for these experiments, so I think that it is the responsibility of the US government to step forward at this time. But it needs to be a global effort and we need a global consensus," NSABB chair Paul Keim told AFP in December.

"This is such a dangerous biological weapon, it would not be controllable. Whoever used it would doubtlessly decimate their own people as well," said Keim.

Soon after, National Institutes of Health experts began working with researchers and editors to pare back the reports for publication, despite outcry from some scientists who said the work must be shared.

Among them was top Dutch scientist Ron Fouchier, who downplayed the threat to biosecurity and told AFP in December that the data "needs to be shared with countries where H5N1 viruses cause outbreaks so that the countries can now be on the lookout if these mutations arise."

However, Fouchier and other top researchers all signed on to the latest letter agreeing to a temporary halt to research.

http://www.google.com/hostednews/afp/ar ... 50e9920.b1

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A Balinese health official holds a chicken to be slaughtered in an attempt to help contro the spread of H5N1 bird flu.




Scientists working on a controversial project to create new forms of H5N1 bird flu agreed on Friday to stop their work for 60 days while the debate plays out.

"We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks," they wrote in a letter published jointly by the journals Science and Nature.

"We propose to do so in an international forum in which the scientific community comes together to discuss and debate these issues," added the letter, signed by 39 scientists including Ron Fouchier of Erasmus Medical Center in Rotterdam, Adolfo Garcia-Sastre of the Mount Sinai School of Medicine in New York and Yoshihiro Kawaoka of the University of Wisconsin.

"To provide time for these discussions, we have agreed on a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals," the letter said. "In addition, no experiments with live H5N1 or H5 HA reassortant viruses already shown to be transmissible in ferrets will be conducted during this time."

Late last year the two teams, one led by Fouchier and one by Kawaoka, created lab-engineered forms of H5N1 bird flu. They said they were trying to see how the virus, which has been circulating since the 1990s, might mutate into a form that could cause a deadly human pandemic.

Other researchers expressed fears about the risk the new viruses could accidentally escape and cause the very pandemic that the scientific community has been worried about. In December, the National Science Advisory Board for Biosecurity, an independent group that advises the federal government, asked the two teams to withhold details of their work.

Supporters of the research say it's key to predicting how H5N1 might mutate and change, as flu viruses often do. But opponents have said the work could be misused by terrorists or that the virus might somehow escape from the lab and spread.

The researchers tried to answer these fears in their letter.

"Despite the positive public-health benefits these studies sought to provide, a perceived fear that the ferret-transmissible H5 HA viruses may escape from the laboratories has generated intense public debate in the media on the benefits and potential harm of this type of research," they wrote.

"We would like to assure the public that these experiments have been conducted with appropriate regulatory oversight in secure containment facilities by highly trained and responsible personnel to minimize any risk of accidental release. Whether the ferret-adapted influenza viruses have the ability to transmit from human to human cannot be tested."

Right now, the H5N1 virus only rarely infects humans and cannot be transmitted very easily from one person to another. But it kills more than half its victims, according to the World Health Organization, which has tallied 343 deaths out of 582 known cases.

http://www.nationaljournal.com/healthca ... h-20120120

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Flu researchers pause for thought

Jan. 20, 2012

Here is a news release issued today, Friday, Jan. 20, by the journal Nature regarding influenza research:

The authors of two H5N1-related papers, to be published in Nature and Science respectively, today announce in those journals their decision to call a voluntary 60-day pause on research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals.

The statement by Yoshihiro Kawaoka, Ron Fouchier and their colleagues, and co-signed by influenza researchers from around the world, outlines how experiments with live H5N1 or H5 HA reassortant viruses — already shown to be transmissible in ferrets — will halt during this time.

This decision has been made in acknowledgment of the fact that the benefits of this research need to be clearly explained, and organizations and governments around the world need time to discuss the best solutions for opportunities and challenges that arise from this work.

The scientists recognize that despite the positive public-health benefits that the currently unpublished work seeks to provide, a perceived fear that the ferret-transmissible H5 HA viruses may escape from the laboratories has generated intense debate in the media on the benefits and potential harm of this research.

The researchers wish to reassure the public that these experiments have been conducted in such a way that minimizes any risk of accidental release, and they say that whether ferret-adapted influenza viruses can be transmitted from human to human cannot be tested.

Elsewhere, in a Nature News story, Declan Butler explores the implications of today’s announcement.

A copy of the full original statement from scientists can be viewed on the Nature press site. Declan Butler’s article is available here.

For more information, please contact:
Yoshihiro Kawaoka (University of Tokyo, Japan; and University of Wisconsin-Madison, WI, USA)
Email: kawaokay@svm.vetmed.wisc.edu
Please note Yoshihiro Kawaoka is traveling and email is the best contact for him.

Alternative contact;
Ruth Francis, Rachel Twinn or Neda Afsarmanesh in the Nature Press Office:
Email: r.francis@nature.com, r.twinn@nature.com, n.afsarmanesh@us.nature.com

http://www.news.wisc.edu/20226

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The avian flu virus could cause a pandemic if it mutates into a form that is more easily transmitted between humans.

Nature
International weekly journal of science
Nature | News

Scientists call for 60-day suspension of mutant flu research


Delay will allow time for debate on regulating potentially dangerous research.
Declan Butler

20 January 2012
As controversy rages around the scientists who created mutant strains of the H5N1 avian influenza virus, leading flu researchers have called for a 60-day voluntary pause on such work. The call comes in a statement jointly published today in Nature (R. A. M. Fouchier et al. Nature 481, 443; 2012) and Science.

On 20 December, the United States government — acting on advice from the US National Science Advisory Board for Biosecurity (NSABB) — asked both journals to publish only the main conclusions of two flu studies, but not to reveal details "that could enable replication of the experiments by those who would seek to do harm” (see ‘Call to censor flu studies draws fire’). The journals and the authors have agreed to this redaction, on the condition that a mechanism is established to disseminate the information to legitimate flu researchers on a need-to-know basis.

The US government, the World Health Organization (WHO) and other bodies are now frantically trying to put together this mechanism, along with a framework for international oversight of such research. The signatories of today’s statement, including the key authors behind the controversial research, say that the pause is intended to allow time for this discussion. “We realize that organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work,” they write.

The scientists add that they intend to organize an international forum to debate the risks and benefits of the research. “We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks,” they write.

“Scientists need to have their voices heard in this debate," says Yoshihiro Kawaoka of the University of Wisconsin-Madison, lead investigator on the paper submitted to Nature and a signatory of today's statement. “We hope that by having a calm and reasoned discussion of the facts, scientists and biosecurity experts can reach a better understanding and find ways to enable the research to go forward while minimizing risks.“

Bioterrorism is just one potential risk of such research. More worrying to some researchers is that if a mutant virus were to accidentally escape from the lab, it could cause a H5N1 pandemic. The authors of the statement say that they hope to "assure” the public that the viruses are in safe hands in secure containment facilities. Such research is currently classed as requiring biosafety level 3 (BSL-3) enhanced containment facilities, but many scientists argue that it should be done only in BSL-4 labs, which have the highest biosafety rating (see 'Fears grow over lab-bred flu').

“I am very much in favour of having a pause,” says Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases (NIAID). He concedes that the length of the pause is not long, but that researchers were concerned about having an open-ended moratorium. “60 days as a start I think is reasonable, and after 60 days we will re-evaluate it,” he says.

“The pause is welcome in the sense that hopefully it will relieve some of the immediate urgency in terms of trying to chart a course forward,” agrees Michael Osterholm, who heads the University of Minnesota’s Center for Infectious Disease Research and Policy in Minneapolis, and is a member of the NSABB.

But he thinks that the duration of the pause is too short. “The 60 days will likely not be adequate in terms of getting a truly workable international policy and applying that. I just don't think that's realistic,” he says. Moreover, the statement makes no mention of any voluntary moratorium on the publication of such work. The NSABB is currently considering recommending one, but given the scale of the controversy over the papers and the moves to establish a data-sharing mechanism, a de facto moratorium may already exist.

The controversy is splitting the scientific and wider community into two camps: those who think that the research should never have been done, and those who feel that it is crucial. What's needed now is to find some middle ground, says Osterholm, for example by assessing what public-health benefits the research realistically offers in the near- and long-term. That should guide decisions as to the levels of acceptable risk, he says, so that the research can proceed “safely, and in a way that does not put the world at potential risk”.
Nature
doi:10.1038/nature.2012.9873

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Commentary

http://www.recombinomics.com/News/01201 ... _Halt.html

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Are Controls on Bird Flu Research a Good Idea?

By Fred Guterl | January 20, 2012|

Two scientists who independently concocted potentially dangerous strains of bird flu viruses—and have had the bioweapons community in a tizzy for the past month with the pending publication of their work—today said that they would suspend their research for 60 days. The announcement is intended to be a kind of time out, a chance for everyone to catch up with the realization that influenza is no longer solely a matter of public health, but is now a potential bioweapon.

The crisis began in December, when the U.S. National Science Advisory Board asked the journals Science and Nature to withhold publication of key aspects of the two papers—to merely to give the results of the research, minus details on methods. (Scientific American is published by Nature Publishing Group.)

The restriction is presumably to keep someone from using the research to make a bioweapon—to make a highly lethal, highly transmissible virus in a lab, and then release it into the wild, so to speak, with the aim of initiating a devastating human pandemic. (Think Al Qaeda, with molecular biologists instead of pilots.)

One irony in this story is that forestalling a doomsday pandemic was a motivation behind the work in the first place—the work that bioweapons defense specialists are now delaying.

Bird flu has been a source of great anxiety among infectious disease specialists at least since 1997, when an outbreak in Hong Kong among poultry farms caused a handful of human deaths. What’s particularly scary about H5N1, as bird flu is designated, is its high mortality rate—it apparently kills 60 percent of those who catch it, as opposed to less than one percent for a typical seasonal flu. Fortunately, fewer than 600 people have died from bird flu, because catching it requires the kind of close contact with birds that sometimes happens on small livestock farms or in the live animal markets in China. The Big Fear is that the genetic roulette wheel will one day turn up a strain of the virus that is not only lethal but also highly transmissible among humans.

What Yoshi Kawaoka of the University of Wisconsin, Madison and Ron Fouchier of Erasmus MC in Rotterdam have done is figure out what mutations are necessary to make bird flu into a truly dangerous human pathogen. The idea is to use this knowledge to monitor the evolution of potential human flu viruses in the wild and on livestock farms, or perhaps to make vaccines and anti-viral medications before such a virus arises in nature. Currently it can take months to make an effective vaccine from scratch—enough time for a flu virus to spread from one end of the globe to another.

Kawaoka and Fouchier not the first scientists to have explored this question, but they are the first to have succeeded. That is what got the attention of bioweapons experts, who are now scrambling to figure out how to get a handle around this threat. They have been concerned about it for years, but until now had been largely theoretical.

What can they do? One tack is to restrict publication to the results of the work but not the methods by which researchers got those results. Whether or not this is effective is a matter of some debate. Some bio-security experts think that the key knowledge is not so much the methods as the fact that the results are possible.

Another avenue is to put international controls on influenza research, much like those placed on nuclear weapons research during the Cold War and still in place today. That would involve putting many constraints on influenza researchers, who are not going to take kindly to this prospect. Effective international controls would be exceedingly hard to work out, not only because scientists will resist them but also because the skills and the equipment needed to produce influenza viruses in the lab are also highly portable—restrict them in a few countries and they’ll likely find a home elsewhere. How do you control this research without squelching it at the same time? That is the puzzle the bioweapons community is grappling with now. They’re unlikely to solve it in 60 days.

In the end, the best defense against deadly pathogens, natural or unnatural, may be knowledge—knowledge of the pathogens themselves, technologies to fight them quickly when they arise, and intelligence (the old fashioned gumshoe kind) about the people who might turn these pathogens against us. As Steven Block, the Stanford biologist, has said: the best defense against biotechnology is more biotechnology.

http://blogs.scientificamerican.com/obs ... good-idea/

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