Man Made H5N1 - Super Version

[sharon sanders]

Re: Man Made H5N1 - Super Version

hat tip Vincent Racaniello -

The 2 hour debate is now posted on the New York Academy of Sciences web site:

"Dual Use Research: H5N1 Influenza Virus and Beyond" Panel Sparks Lively Debate

The New York Academy of Sciences hosts a panel of leading scientists, publishers, and ethicists who discuss issues surrounding controversial H5N1 research.

here:

http://www.nyas.org/MemberCenter/AcademyNews.aspx?cid=8c61a204-36f6-4df8-8bd2-059882c5e287

[Shiloh]

Man Made H5N1 - Super Version

Source: http://www.cidrap.umn.edu/cidrap/con...1512forum.html

Forum: H5N1 research tussle shows need for clear policies
Robert Roos * News Editor

Feb 15, 2012 (CIDRAP News) ? The acute need for clearer policies concerning the handling of potentially risky life-sciences research was the main theme that came across today in a Harvard forum on the controversy over studies on H5N1 avian influenza viruses with increased transmissibility.

"This is an area that is really ripe for policy definition," said Jean Guillemin, PhD, senior advisor in the MIT Security Studies Program and author of the book American Anthrax, one of four experts who participated in the hour-long discussion, which was presented by the Harvard School of Public Health.

Others on the panel spoke of the need for policy discussions at the international level. The first such discussion will begin tomorrow, when the World Health Organization (WHO) convenes a group of experts in Geneva to talk about issues raised by the two H5N1 studies.

The two studies involved the generation of an H5N1 virus and an H5N1-H1N1 reassortant that spread among ferrets by the airborne route. In December the National Science Advisory Board for Biosecurity (NSABB), which advises the Department of Health and Human Services (HHS), recommended that the details be deleted from the two reports before they are published. HHS agreed and passed the recommendation to Science and Nature, the journals considering publishing them.

The two journals have said they will go along with the recommendation if a way can be found to provide the details of the reports to scientists with a legitimate need for them. But since the NSABB recommendation was unveiled, scientists, biosecurity experts, and public health officials have vigorously debated the issue in the media and in journal commentaries.

Today's forum, which was streamed over the Web, was shorter and less heated than a discussion presented on Feb 2 by the New York Academy of Sciences. In that session, experts supporting and opposing the NSABB recommendation argued about the threat represented by the mutant viruses, the potential public health benefits of the research, and related issues.

Biodefense vs public health
The general shape of H5N1 research controversy was sketched by panelist Marc Lipsitch, PhD, professor of epidemiology at the Harvard School of Public Health and director of the Center for Communicable Disease Dynamics. He was followed by Barry R. Bloom, DSc, PhD, former dean of the school and a professor in its Department of Immunology and Infectious Diseases, who outlined the major arguments and counterarguments in the debate.

The central questions, Bloom said, come down to two: "What do we publish, what do we make available? And how do we work with recombinant viruses?"

Guillemin said the controversy has exposed the divide between the biodefense and public health worlds. By way of background, she noted that the spate of biodefense funding unleashed by the terrorist attacks of 2001 focused initially on class A bioterror pathogens, including anthrax, plague, and smallpox.

But over the years the emphasis shifted to global emerging diseases (such as H5N1), a category that now claims about 60% of the money, while about 28% goes to the bioterrorism area. The SARS (severe acute respiratory syndrome) epidemic of 2003 did much to shift the emphasis away from bioterrorism, she said.

"Uniting the bioterrorism threat with the infectious disease threat meant the merger of two very different camps," Guillemin said. "The biodefense mentality is very allied to a military mentality of getting ahead of the enemy. You try to figure out what the pathogens are going to do and get ahead of them."

In defense research, secrecy is one of the things scientists routinely accept in return for their funding, she went on. In contrast, she said, "From the public health point of view, the idea is that the protection of the public is an absolute priority, and secrecy is the last thing you want.

"You can look at all sorts of outbreaks . . . where secrecy was a factor in the playing out of an epidemic, and people died. That's a very strong public health position. There is kind of a conflict of cultures."

This conflict points up the need for clear policies on the conduct and dissemination of potentially dangerous research, she added.

The other panelist was David R. Franz, DVM, PhD, an NSABB member and former commander of the US Army Medical Research Institute of Infectious Diseases. He expressed concern about the ability to mount an adequate public health response if a highly transmissible H5N1 virus got loose.

The powerful tools now available to life-sciences researchers have been used for good and will continue to be used for good, he said, "But we can't ignore the possibility that they'll be used for harm."

"This particular virus is special," he said, referring to the mutant viruses generated in the two studies. "This is one that has really made us stand up and take notice."

Lab safety worries
"We may not be able to mount an appropriate and adequate public health response for something like this . . . if it were lethal and transmissible," Franz added. "I'm not sure we could get medical countermeasures to the right places and in the right quantities. On this one I'm more concerned about [lab] safety than about security. I think there'll be more scientists working in legitimate labs on bugs like this than bioterrorists working in caves."

Lipsitch said the H5N1 studies are valuable because they remind the world that the H5N1 pandemic threat is real in the face of growing complacency. At the same time, he seconded Franz's concern about the risk of lab accidents that could release the mutant viruses. He noted that the two H5N1 studies were done in biosafety level 3 (BSL-3) labs, a notch below the top biosecurity level.

"I feel strongly that this [research] should be done under very high containment," he said. "On balance I'd favor redacting the details [of the studies], but I don't feel as strongly about that as about the containment issue. This should not be in hundreds of labs around the world."

Bloom dissented on the need to use BSL-4 restrictions for this type of research: "I disagree with Marc on working in extreme containment. Working in a space suit and rubber gloves seems like a way to predispose to accidents and spills. Containment is in your fingers and concentration and in the training you have."

Skepticism on bioterrorism
The panelists voiced some skepticism about the risk of bioterrorist exploitation of the H5N1 studies. Guillemin said such an eventuality would be "amazing," commenting, "the one case we had, if the FBI is right, came from an insider at a military lab."

Panel moderator Sharon Begley, senior US health and science correspondent for Reuters, noted that one of the H5N1 viruses was generated by passing it 10 times through ferrets. She asked if someone with a B.S. degree and access to mail-order could do that.

Lipsitch replied that both experiments involved a combination of genetic engineering and passaging in ferrets. To suggest that terrorists in caves are the main concern is a little misleading, he said, adding, "There are countries that have aspirations to cause destruction in other countries, and they have a certain amount of technical sophistication."

Bloom said his view is that "transparency and openness is the best constraint for people intending to do harm." He added, "The general public of all countries should know what we're up to and know that there are people concerned about their safety."

Bloom and Franz both called for global discussions to develop policies on dual-use research.

"I hope the WHO meeting will lead to clear guidance," said Franz. "But more important, I hope that in future they might bring together the other 190 states of the world that have a vote and are involved, so that we might think about this as a truly global problem."

Guillemin called for the United States to take the lead: "I think the US leads the way in defining norms and policies that influence the rest of the world, and I think it would be wonderful if we could hold a kind of Asilomar conference . . . to talk about how the money should be spent." She referred to a conference in 1975 at which scientists developed guidelines for research involving recombinant DNA.

See also:

Harvard School of Public Health forum page

Feb 15 CP story on the WHO meeting

Feb 3 CIDRAP News story "Live debate airs major divisions in H5N1 research battle"

[sharon sanders]

Re: Man Made H5N1 - Super Version

I would like to see some non "experts" participating on these panels.

What about the real stakeholders? Us.

[tetano]

Re: Man Made H5N1 - Super Version

Virus mutant H5N1: beginning of a meeting closed at WHO in Geneva




Geneva - 20 experts met Thursday behind closed doors at the headquarters of the world Organization of health (who) to determine whether the scientists involved in the development of a mutation of the H5N1 virus capable of transmitting between humans can publish their studies.The meeting, which will continue Friday, started at 09: 00 local (08 H 00 GMT), told AFP a who spokesperson, Gregory Hartl.Sur 22 participants that must attend this technical consultation, 21 arrived and one is overdue, he said.Participants include teams of the two researchers and representatives of scientific journals Science and Nature which should publish the results of the studies.The meeting aims to reach a consensus among researchers, studies conducted on H5N1 influenza virus changes to make it more transmissible between humans has raised concerns in the international community on risks and abuse.Because if the avian influenza virus H5N1 is particularly transmissible between birds, when it is transmissible to man, it is 60% fatal, according to the who.

http://www.romandie.com/news/n/_Virus_mutant_H5N1_debut_d_une_reunion_a_huis_clos_a_l_OMS_a_Geneve160220121002.asp

[Shiloh]

Man Made H5N1 - Super Version

Source: http://uk.reuters.com/article/2012/0...81G1BD20120217

Deadly bird flu studies to stay secret for now - WHO

GENEVA | Fri Feb 17, 2012 4:58pm GMT

GENEVA (Reuters) - Two studies showing how scientists mutated H5N1 bird flu into a virus that could create a human pandemic will be made public eventually, but a moratorium will remain for biosecurity officials to assess the risks, the World Health Organisation (WHO) said on Friday.

Speaking after a high-level meeting of flu experts and U.S. security officials in Geneva, a WHO spokesman said an agreement had been reached in principle to publish the controversial work only after deeper risk analyses have been carried out...

[sharon sanders]

Re: Man Made H5N1 - Super Version

Thanks Shiloh.

Sometimes I make a copy of a post for this thread too.



The WHO just finished the press conference. There will be an audio and written version available later today.

[sharon sanders]

Re: Man Made H5N1 - Super Version

Public health, influenza experts agree H5N1 research critical, but extend delay

WHO to convene additional meeting to discuss future protections

News release

17 FEBRUARY 2012 | GENEVA - A small group of global public health and influenza experts at a WHO-convened meeting reached consensus on two urgent issues related to the newly created H5N1 influenza viruses: extending the temporary moratorium on research with new laboratory-modified H5N1 viruses and recognition that research on naturally-occurring H5N1 influenza virus must continue in order to protect public health.

?Given the high death rate associated with this virus -- 60% of all humans who have been infected have died -- all participants at the meeting emphasized the high level of concern with this flu virus in the scientific community and the need to understand it better with additional research," says Dr Keiji Fukuda, Assistant Director-General of Health Security and Environment for the World Health Organization. ?The results of this new research have made it clear that H5N1 viruses have the potential to transmit more easily between people underscoring the critical importance for continued surveillance and research with this virus.?

WHO convened the meeting as a first step to facilitate the discussion of differing opinions that have arisen in recent months after two research groups, one in the Netherlands and the other based in the United States, have created versions of the H5N1 influenza virus which are more transmissible in mammals than the H5N1 virus that occurs naturally.

The experts at the meeting included lead researchers of the two studies, scientific journals interested in publishing the research, funders of the research, countries who provided the viruses, bioethicists and directors from several WHO collaborating-center laboratories specializing in influenza.

Consensus to delay publications

The group also came to a consensus that delayed publication of the entire manuscript would have more public health benefit than urgently partially publishing.

?There is a preference from a public health perspective for full disclosure of the information in these two studies. However there are significant public concern surrounding this research that should first be addressed,? says Fukuda.

Two critical issues are to increase public awareness and understanding of this research through communications and the review of biosafety and biosecurity aspects raised by the new laboratory-modified H5N1 influenza virus. WHO will continue discussion with relevant experts to move this forward.

Broad issues raised, but not limited to, these research studies will be discussed at future meetings convened by WHO soon with participation by a broader range of experts and interested parties relevant to these issues.

http://www.who.int/mediacentre/news/releases/2012/h5n1_research_20120217/en/index.html

[Pathfinder]

Re: Man Made H5N1 - Super Version

NIH Statement on H5N1 and the World Health Organization Meeting

February 17, 2012

Today, an international group of public health and influenza experts convened by the World Health Organization (WHO) concluded a two-day meeting examining issues regarding two unpublished manuscripts that describe National Institutes of Health (NIH)-funded research on the transmissibility of H5N1 influenza. We continue to stand by the December 2011 recommendations of the National Science Advisory Board for Biosecurity (NSABB) but we intend to consider carefully the information discussed during the WHO-hosted meeting. We remain committed to the advancement of scientific inquiry to improve public health while balancing national security concerns.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health

http://www.nih.gov/about/director/02172012_h5n1_statement.htm

<!-- InstanceEndEditable -->

[Pathfinder]

Re: Man Made H5N1 - Super Version

Canada confines mutant flu to maximum-security facilities

<TIME datetime="2012-02-23T14:50:47+00:00" pubdate><ABBR class=value title=2012-02-23>23 Feb 2012 </ABBR>|<ABBR class=value title=14:50:47+0000> 14:50 GMT</ABBR></TIME> | Posted by Declan Butler |

Excerpt:

Declan Butler asked Sandra Fry, director-general of the Public Health Agency of Canada?s Pathogen Regulation Directorate, and Marianne Heisz, head of the directorate?s Office of Biosafety Programs and Planning, how the agency reached its decision to classify work on the new lab strains as requiring BSL-4 (note that Canada uses the term ?CL? in place of BSL) facilities.

Read the Q&A under the fold.

What prompted Canada to review the biosafety level of the new flu viruses and give them the highest RG4/BSL-4 rating?

The Public Health Agency of Canada (PHAC) is the national authority for human pathogen oversight, and administers and enforces the Human Pathogens Importation Regulations and the Human Pathogens and Toxins Act, which require any person in Canada importing or working with human pathogens to follow national biosafety requirements, specifically, the Laboratory Biosafety Guidelines. PHAC routinely reviews the scientific literature and conducts risk assessments on human pathogens, and assessments of new or emerging pathogens that result in new or altered biosafety requirements for working with that pathogen lead to the issuing of a Biosafety Advisory. Communicating the outcome of the risk assessment through a biosafety advisory raises awareness among PHAC?s regulated parties of the containment level requirements for biosafety and biocontainment for these specific viruses. Transmissible forms of the highly lethal H5N1 virus clearly meet the definition of an RG4 human pathogen, and should thus be handled under CL4.

How did you weigh up what was an appropriate biosafety rating?

The Human Pathogens and Toxins Act states that RG3 human pathogens pose a high risk to the health of individuals and low risk to public health. RG4 human pathogens are pathogens that pose a high risk to the health of individuals and a high risk to public health. These pathogens are likely to cause serious disease in a human and there are generally no effective treatments or preventative measures available. The risk of spread of disease caused by RG4 human pathogens is high.
PHAC completed a risk assessment on the H5N1 viruses that were engineered in the Netherlands and the United States taking into account their transmissibility in ferrets, which involved careful consideration of specific pathogen characteristics including pathogenicity, route of infection, and communicability. Although the H5N1 virus circulating in nature poses a serious risk to human health, human-to-human transmission of H5N1 occurs inefficiently, and this limited transmissibility has restricted the spread of H5N1 and is the main factor that distinguishes this pathogen as Risk-Group 3. By modifying H5N1 to be efficiently transmissible, including via aerosols, the risk to public health would increase vastly, as every primary infection could potentially lead to multiple secondary infections.

PHAC decided that, based on the severe impact on human health, high risk to public health, and uncertainty about the availability of effective preventative and therapeutic measures, the engineered H5N1 viruses should be rated as RG4 viruses.

One of the criteria in designating a pathogen as requiring BSL-4 facilities is that effective drugs and vaccines are not available. How do you apply that criterion to these new flu strains, given that although some H5N1 vaccines and drugs do exist, in practice there wouldn?t be remotely near enough of them should the virus escape from the lab and spread in the community?

The availability of effective preventative or therapeutic measures is a factor considered when conducting a pathogen-risk assessment. Although H5N1 vaccines have been developed, the research in question involves the deliberate modification of H5N1, and we have not yet determined how effective existing vaccines would be against the modified viruses. In considering the potential impact of a release of transmissible H5N1 into circulation, the availability of effective medical intervention and the capacity of the health-care response system will need to be determined. PHAC considered these and other factors, and they weighed into the conclusion that this pathogen is to be worked at in CL 4.

Did you consult with researchers, and what was their opinion?

Several experts in the field of biosafety were consulted in the development of the engineered H5N1 viruses Biosafety Advisory. As part of our standard Biosafety Advisory development process, the risk assessment is conducted in collaboration with researchers at the PHAC National Microbiology Laboratory (NML), and with our colleagues from the Canadian Food Inspection Agency (CFIA) for expertise on the animal pathogen component. Additional rigour was added by consulting with public-health experts through the Canadian Public Health Laboratory Network (CPHLN). There was general agreement that transmissible H5N1 should be handled at the highest level of containment.

...
Full text:

http://blogs.nature.com/news/2012/02/canada-confines-mutant-flu-to-maximum-security-facilities.html

[gsgs]

Re: Man Made H5N1 - Super Version

http://www.ncbi.nlm.nih.gov/pubmed/22056389

we identified four variant viruses with amino acid substitutions in the
hemagglutinin (S227N, D187G, E190G, and Q196R) that revealed modestly
increased α2-6 and minimally decreased α2-3 binding
combining Q196R with (Q226L and G228S) gave good α2-6 binding.
Unlike the wild type H5N1, this mutant virus was transmitted by direct
contact in ferrets but not by airborne respiratory droplets.
However, a reassortant virus with the mutant hemagglutinin,
a human N2 neuraminidase and internal genes from an H5N1
virus was partially transmitted via respiratory droplets.
The complex changes required for airborne transmissibility in ferrets
suggest that extensive evolution is needed for H5N1 transmissibility
in humans.

[sharon sanders]

Re: Man Made H5N1 - Super Version

hat tip Michael Coston

Tuesday, February 28, 2012

Webcast: Discussion Of NSABB’s H5N1 Recommendations




# 6181

My thanks to Helen Branswell for tweeting this event.

Set you alarm clocks accordingly, as tomorrow morning (Wednesday, February 29th) the ASM Biodefense and Emerging Diseases Research Meeting will provide a live webcast of an hour-long discussion over the NSABB’s recommendations to redact portions of two H5N1 research papers.


Featuring:
Michael T. Osterholm, Ph.D., MPH NSABB/CIDRAP
Anthony S. Fauci, M.D (NIAID)
Bruce Alberts, Ph.D. Editor-in-Chief of Science
Ron A.M. Fouchier, Ph.D. H5N1 Researcher

Live Stream Details
Date: Wednesday, February 29, 2012
Time: 7:15 a.m. - 8:15 a.m. EST
Link:

If you are unable to watch the live feed, a video should be posted by 1:00pm.

Posted by Michael Coston at 12:53 PM

[Pathfinder]

Re: Man Made H5N1 - Super Version

Death Toll Mounts in Indonesia as Battle Rages Over Bird Flu Study

Dessy Sagita | February 28, 2012

...
Indonesian opinions on the publication controversy are mixed. Chairul Anwar Nidom, a virologist with the Tropical Disease Center at Airlangga University in Surabaya, is in favor of full transparency in the interest of preventative research.

?The delay of these publication should be a big concern to us as the country with the most severe cases of bird flu, especially if the delay is imposed due to unreasonable fears such as over terrorism,? Nidom said.

He added that he found it difficult to believe the journals would have agreed to delay the publication of such important studies without being coerced.

?I know the researcher from University of Wisconsin. He?s a friend of mine, and he said he was disappointed with the publication delay,? he said. ?The delay plunges us into darkness. We are once again prevented from getting the information we desperately need.?

Nidom said he was interested to learn why there was a greater fatality rate among ferrets in the Erasmus study, which used virus strains isolated from Indonesian patients, compared to the study in Wisconsin, which used a strain collected in Vietnam.

?We need to know why more ferrets in the Netherlands died. Is it because the virus was from Indonesia and thus more deadly?? he said.

Nidom claimed the US agency?s fear of terrorism was overblown and naive because the threat of bioweapons did not depend only on bird flu.

He said scientists around the world, including in Indonesia, have been trying to alter the bird flu virus and make it more dangerous for a positive purpose.

?In the end what we want is not just to create a more deadly virus, we want to measure how dangerous the virus can be, and we want to find a better cure,? he said.

Emil Agustiono, an epidemiologist and secretary of the National Committee on Zoonosis, which is the study of diseases that can be passed from other animals to humans, begged to differ. He said publishing such controversial research would not be beneficial.

?I highly doubt those two studies will be published at all, simply because I don?t see any benefit,? he said.

Emil said the danger of human to human transmission of bird flu was still far away.

?Without publishing such studies people already know that mutation is possible, but until now there is no evidence that it could happen naturally,? he said. ?We don?t need to be so worked up about something that isn?t happening yet. We would be better off focusing our energy on the current situation.?

Emil dismissed Nidom?s concern that the only antiviral drug for bird flu, Oseltamivir, was no longer effective against the disease, and doubted that the unpublished studies could take Indonesia a step closer to a new cure.

?Oseltamivir is still very much effective. The problem is not the drug, but early detection because bird flu symptoms resemble many other diseases, including dengue, so victims usually don?t get treatment in time,? he said.

Tjandra Yoga Aditama, the Health Ministry?s director general of disease control and environmental health, who attended the WHO meeting in Geneva, said the whole situation surrounding the study of bird flu was problematic. He said the risk of public hysteria was a factor that should be taken into account.

?Any kind of research can be beneficial as well as harmful, it?s a double-edged sword, that?s why it takes time to inform the public what the research is all about,? he said.

Tjandra said the government did not support the publication of redacted studies, because they would not benefit anyone.


Full text:

http://www.thejakartaglobe.com/news/death-toll-mounts-in-indonesia-as-battle-rages-over-bird-flu-study/501310#Scene_1

[Shiloh]

Re: Man Made H5N1 - Super Version

Source: http://www.ctv.ca/CTVNews/Health/201...tudies-120229/

Home : Health : U.S. panel asked to take another look at bird flu studies
U.S. panel asked to take another look at bird flu studies

The Canadian Press

Date: Wednesday Feb. 29, 2012 1:42 PM ET

A panel of U.S. biosecurity experts is being asked to review its recommendation that two controversial bird flu studies shouldn't be published in full, a biosecurity conference was told Wednesday.

The group, the National Science Advisory Board for Biosecurity, will be given revised versions of the manuscripts of the studies, said the senior U.S. official who revealed the information.

One of the revised manuscripts in particular will clarify that an H5N1 virus made in a Dutch laboratory was not as lethal as has been suggested publicly to date, the meeting was told.

Ron Fouchier, the Dutch virologist who led one of the two research projects, told the conference the virus his lab created did spread easily among ferrets housed in adjacent cages.

But none of the ferrets infected that way died, Fouchier said. Only ferrets that were directly infected -- with high doses of virus dripped into their trachea -- were killed by the lab-made virus.

Those results have not been made public to date and actually contradict much of the information that has circulated about Fouchier's study since the NSABB recommended against its full publication last November.

Previously Fouchier has been quoted as saying all the ferrets in his study died after being infected by the mutant H5N1 virus. He was not immediately available Wednesday to explain how the misconception about his work arose.

The other study, led by virologist Yoshihiro Kawaoka of the University of Wisconsin-Madison, reports on the creation of a different lab-made virus, a hybrid of H5N1 and human H1N1 viruses. Kawaoka has already revealed that the hybrid his lab produced spread easily among ferrets, but did not kill the animals.

Dr. Anthony Fauci, head of the U.S. National Institute for Allergy and Infectious Diseases, told the conference -- staged by the American Society of Microbiology -- that the NSABB will be reconvened to review the clarified data.

In an interview after the meeting, Fauci said he cannot prejudge what the group will decide, though he hopes a decision can be taken "within weeks."

The chair of the NSABB, virologist Paul Keim, told the meeting he cannot say what impact the revised information will have on the opinions of the advisory body...

[sharon sanders]

Re: Man Made H5N1 - Super Version

RISK ASSESSMENT

Laboratory-created A(H5N1) viruses transmissible between ferrets
29 February 2012RISK ASSESSMENT Laboratory-created A(H5N1) viruses transmissible between ferrets

Executive summary

The results of two, as yet unpublished, investigations of laboratory-induced genetic changes in avian influenza A(H5N1) viruses have been reported to have found that a surprisingly few number of changes make the viruses transmissible between ferrets, the most commonly used model for the way influenza behaves in humans. The possibility that this could have resulted in the development in laboratories of A(H5N1) influenza viruses transmissible between humans has caused concern for public safety and generated unusually high levels of debate, especially in the United States. The American authorities that are funding the work have requested that part of the scientific papers (carried out independently in the USA and the Netherlands) be restricted because of a fear that this could represent dual-use research and development, i.e. research that could be used for malign as well as good purposes. An almost unprecedented voluntary moratorium on the research has been declared by the groups capable of undertaking such research, including six European groups.

These developments have raised a complicated series of interlocking issues: Public concern that laboratory modified H5N1 viruses could accidentally cause an influenza pandemic; the need for assessment of the balance of public health risk and benefit in research; appropriate laboratory biosafety requirements of research on the evolution of pathogens to become more virulent or transmissible; the need and ability to revise risk assessments concerning A(H5N1) viruses; a potential threat to the new pandemic influenza preparedness framework forinfluenza virus and benefit sharing; and academic freedom to publish.

To resolve some of these issues WHO held a successful first meeting of the principals involved in the research and its publication (16–17 February 2012, Geneva). That meeting achieved a considerable degree of consensus, including the view that progress in this research area was vital to global health security, that the suggested mechanism of restricting publication was undesirable and impractical in the short term and that the moratorium on research should continue. It was agreed that wider meetings were now needed and that there should be a further review of laboratory biosafety both in the laboratories concerned and generally for this kind of research. Finally it was recommended that considerable public communication work was needed to explain the importance of the research work that is now on hold.

This risk assessment report summarises and explains the complex public health and scientific issues around these developments including the positive and negative aspects of some of the responses that have been proposed internationally. These proposed measures include withholding the research methodologies and genetic sequences from publication, destruction of the created viruses, raising their biosafety classification, handling them in maximum biosafety and security facilities and conditions, and restricting the numbers of institutions and groups working in the field. This document’s starting point is that without sight of data and analyses it is very difficult to undertake risk assessments. It is not even clear at present how pathogenic these viruses are in animal models. The document also puts forward the ECDC position on some of these issues according to ECDC’s limited mandate, recognising the value of the research but also the potential risks. ECDC stresses the need to consider mechanisms for a robust biorisk-management approach along the lines of international standards and EU-wide guidance on laboratory biosafety/biosecurity for any future emerging threats. ECDC indicates that it would advocate open publication of the findings and emphasises the importance of sustaining and enacting the pandemic influenza preparedness framework with its underpinning global virological surveillance and sharing of information and benefits in order to enhance global health security. It is ECDC’s intention to support the European Commission and Member States, to monitor these developments closely and with its stakeholders and collaborators to revisit its risk assessment for A(H5N1) viruses as the research findings emerge.

Enquiries concerning this document should be directed to the ECDC Chief Scientist Johan Giesecke,
johan.giesecke@ecdc.europa.eu

http://ecdc.europa.eu/en/publications/Publications/TER-RA-120229-Laboratory-created-A-H5N1-viruses-transmissible-between-ferrets.pdf

[Shiloh]

Re: Man Made H5N1 - Super Version

Source: http://www.medscape.com/viewarticle/759465

H5N1 Research Discussed in Special Session at ASM
Troy Brown

February 29, 2012 (Washington, DC) ? A panel of prominent scientists expressed their agreement with steps taken so far regarding the publication of controversial research results on the H5N1 influenza virus at a session hastily convened today at the American Society for Microbiology (ASM) meeting on biodefense and emerging diseases. ASM organized the extra session to provide time for the discussion of recent recommendations by the US National Science Advisory Board for Biosecurity (NSABB)...