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Man Made H5N1 - Super Version

Re: Man Made H5N1 - Super Version

Little consensus at scientific meeting on releasing results of risky research

By David Brown, Published: April 4

The audience of about 200 scientists and ethicists considered numerous questions.

Are there experiments so pointless and dangerous that they should never be done? Are there experiments that might be useful but are too dangerous to be done? Is there any purpose in reporting that something has been accomplished without saying how it was done?

There was general agreement that some experiments are off limits, such as attempting to make the AIDS virus transmissible by air. There was less agreement about the experiments at hand, which changed the characteristics of H5N1 bird flu.
...
The rationale for the work is that it will give virologists and epidemiologists an idea of what worrisome mutations to look for when they analyze samples of H5N1 viruses collected from birds around the world.

But Thomas Inglesby of the Center for Biosecurity of the University of Pittsburgh said knowing the mutations that enhance contagiousness would have no practical use. That?s because the current response to H5N1 outbreaks in chickens is to kill all the birds ? at least in the countries that have a public health response.

?What would be done differently?? he asked.
...
John Savill, head of the Medical Research Council (Britain?s non-governmental equivalent of the National Institutes of Health), ...

?My view is publish and be damned,? he said.

Full text:
http://www.washingtonpost.com/natio...sky-research/2012/04/04/gIQApRpRwS_story.html
-------------------------------------------------------

Definition of publish and be damned from the Oxford Advanced Learner's Dictionary

a phrase meaning ?you can publish if you like, I don?t care?. It is thought to have been used by the Duke of Wellington when he received threats that private details about him were going to be published. It is now used more often when someone decides to publish something offensive or unpopular even though they know they will face public criticism

A lot of people will disagree with what I?ve written ? I?ll just have to publish and be damned.

http://oald8.oxfordlearnersdictionaries.com/dictionary/publish-and-be-damned
 
Re: Man Made H5N1 - Super Version

A letter from NSABB member Michael Osterholm to Amy P. Patterson, M.D. Associate Director for Science Policy at National Institutes of Health



Summary

In short, the NSABB March meeting should be a very important learning experience for the USG, the journal editors, and life scientists in general as to the need for a much more effective system to address DURC issues. One primary lesson that I believe is critical: The Board must involve disinterested subject matter experts to provide technical advice. I believe that the relative lack of subject matter expert input from those without a direct interest in the Board’s decision be viewed critically by the larger policy and life science communities as the decision is debated over the upcoming days.

As I stated before, I believe our recent experience is just the beginning, not the end of this type of scientific and policy conflict. As a said to Dr. Collins toward the conclusion of the March meeting, I wouldn’t want to be in his shoes sitting before a Congressional hearing trying to explain why the NSABB and likely the USG supported the full Fouchier publication when we heard at the meeting that he has done more work and found one additional mutation that now confers H5N1 transmissibility between mammals without ferret passage. How will we justify one more “incremental finding paper” that now is a pretty complete cookbook when we didn’t recommend redaction for the vast body of his work? If we believe redaction of the current manuscript is problematic in terms of international agreements, I think the next mutation paper will prove to be the straw that breaks the camel’s back. It is unfortunate that the current NSABB action just kicked the can down the road to the next manuscript. I hope these comments are helpful as the NSABB moves forward. As someone who will soon be rotating off the Board after 7 years of service, I believe now, more than ever, of its importance.

Thank you for the honor and opportunity to participate.

Sincerely,
Michael T. Osterholm, PhD, MPH
Director, Center for Infectious Disease Research and Policy

http://news.sciencemag.org/scienceinsider/NSABB letter final 41212_3.pdf
 
Pot calling the kettle black?

Pot calling the kettle black?

It is strange that Michael Osterholm should be using this argument when I often felt exactly the same way, in reverse, when this issue was being actively debated. When the The New York Academy of Sciences' debated with Osterholm on the panel, and dominating it, the boot was very much on the other foot.
While the NSABB kick-started the debate as to where the the risk/benefit line should be drawn, a debate worth having, it does not give them the right to a seat at the table when decisions are made. They are, after all, only an advisory body on one topic to one government, among hundreds, in a debate on issues with global consequences. They may influence US internal regulation but that is not much of a fire-break if any resultant regulation just moved US researchers off shore, and would have no influence over anyone else anyway.
Any reasonably useful solution will need to be forged under the UN/WHO umbrella.
 
Re: Man Made H5N1 - Super Version

did most of the participants have a personal interest in the outcome ?
Get some "judges",some statisticians to decide independently ....

And remember the decision in 1976, how it was made, the CDC-panel,
Alexander questions,.... later books were written about it,
how to make such sorts of decisions, apparantly now forgotten.

And I don't think you can decide that issue without making estimates
of the thread, the probabilities.
They were hardly trying to do this, talking around the really critical issue,
not weighting the factors but rather adding new considerations while
ignoring the counterarguments

And I feel that we need more international initiative on this.
New treaties to confirm or form a consensus on how to handle
this research, to condemn and control and inhibit H5N1 use
for weapons. And this consensus should include terrorist
organisations ong rogue states.

Publically announcing that they keep the option for such weapons,
should be critical for their support on those who sympathize and follow them.
 
Re: Man Made H5N1 - Super Version

Michael Coston's comment:

FRIDAY, APRIL 13, 2012
ScienceInsider: A Flawed Flu Papers Process?

http://afludiary.blogspot.com/2012/04/scienceinsider-flawed-flu-papers.html

# 6283





The `must read’ for today comes from the pen of CIDRAP director and NSABB board member Michael Osterholm in a letter to the Associate Director for Science Policy at the NIH where he critiques the NSABB’s recent reversal of their previously unanimous decision to block the full publication of Ron Fouchier’s controversial H5N1 ferret studies.


Of the eighteen members who voted again on the issue, twelve recommended publication while six did not. Osterholm voted in the minority.


Jon Cohen writing for Science’s ScienceInsider provides the background, in his report:




A Flawed Flu Papers Process?
by Jon Cohen on 13 April 2012, 4:26 PM

Last month, one-third of the members of the U.S. National Science Advisory Board for Biosecurity (NSABB) disagreed with the group's recommendation to publish in full two studies that describe how to make the bird flu virus transmissible in mammals. Now one of the six dissenters, influenza epidemiologist Michael Osterholm of the University of Minnesota, Twin Cities, has written a sharp critique of the meeting that led to the decision. In a letter sent yesterday to Amy Patterson, an official at the U.S. National Institutes of Health whose office oversees NSABB, Osterholm charged that the meeting was "designed to produce the outcome that occurred."
(Continue . . .)


Osterholm’s 7-page letter is available HERE - and regardless where you stood on the publication of Fouchier’s research - Osterholm calls into serious question many aspects of the NSABB review process that should be of concern to all of us.


Helen Branswell has even more on all of this in her recently updated Canadian Press story:



Updated: April 13, 2012 | 6:39 pm
Flu expert slams bird flu panel process
By Helen Branswell The Canadian Press





In a world where we can now create `designer’ organisms in the laboratory, the biosecurity issues facing life sciences research are becoming increasingly complex. While the benefits of this kind of work may prove enormous, the risks are not trivial.



Despite reassurances from researchers, mistakes, laboratory accidents, and even intentional misuse of these new technologies are always possible.


Against this backdrop, public confidence in science and scientists continues to deteriorate (see Science at the Crossroads). Already there is a good deal of public resistance to the use of GM (Genetically Modified) food crops, and bio-engineered organisms, and the anti-vaccine movement continues to thrive.



If this type of research is to have a viable future, then it must first engender the public’s trust.


And based on their handling of this controversy over the past few months, the scientific community has got a long way to go.
 
Last edited:
Re: Man Made H5N1 - Super Version

A recent comment by Vincent Racaniello:

More evidence for mild influenza H5N1 infections

12 APRIL 2012
Influenza H5N1 virus frightens many because of the widely quoted case fatality ratio of >50%, which is based on the number of deaths among the fewer than 600 cases confirmed by the World Health Organization. Such fear is misguided, because it is likely that the fatality ratio is far lower. For example, studies of >7,000 healthy individuals have revealed that about 0.5% of them carry antibodies to the virus in their blood, indicating that mild or asymptomatic infections do occur. T-lymphocytes that recognize influenza H5N1 virus have now been detected in a high-risk cohort of individuals in Vietnam, providing additional evidence for asymptomatic human infections.

Viral infection of a healthy host usually leads to the production of both antibodies and lymphocytes. Antibodies generally bind to virus particles in the blood and at mucosal surfaces, blocking the spread of infection. In contrast, T-cells recognize and kill infected cells. The presence of specific antibodies has historically been used as an indicator of viral infection, partly due to the simplicity of the assay. In practice, dilutions of patient sera can be mixed with infectious virus to measure its ability to block infection (virus neutralization or hemaggultination-inhibition), or used to detect antibodies to viral proteins (ELISA or western blot).

Another option for assessing previous viral infection is to determine whether virus-specific T-cells are present. In the past this type of assay has been difficult to carry out with large numbers of samples, but technical advances have now made it possible to do population screens for T-cell responses. In the current study, peripheral blood mononuclear cells (which contain T-lymphocytes and other blood cells) were obtained from patients and placed in culture. Next, pools of overlapping peptides that span most of the influenza viral proteins were added to the cells. These peptides were derived from influenza H5N1, H3N2, and H1N1 proteins. When T-cells recognize a peptide (via the T-cell receptor that recognizes the peptide presented by another cell type; see figure), the cells respond by producing interferon gamma, which can be readily measured.

The Vietnamese patients used for this study were part of a rural community where human and avian infections with influenza H5N1 had been previously documented. Twenty-four of of 747 individuals had evidence for the presence of T-cells that recognize peptides from the H5 HA more strongly than peptides from H3 or H1 HA. Another 111 samples had T-cells that react with H5, H1, and H3 peptides. If all positive patient samples (those lead to production of interferon gamma) are included, then one can conclude that 20% of the patients respond to H5 peptides. Control samples (n=271) were obtained from two individuals in Vietnam and the United Kingdom who are not believed to have been exposed to H5N1 virus. None of these had H5N1-specific T-cell responses.

Curiously, only four subjects had both antibody and T-cell responses to H5N1 virus. The timing of sample acquisition with respect to infection is likely to be important for detecting responses. For example, antibody to H5N1 virus may not be detected earlier than 3 weeks after onset of disease, and T-cell responses may wane with time. It is also possible that abortive H5n1 infections in humans may lead to production of T-cells but not antibodies, as is seen in some individuals infected with HIV-1.

These findings provide additional evidence for subclinical human infection with influenza H5N1 virus. Exactly how many of people in the Vietnamese cohort were infected cannot be determined. Some of the H5-specific responses likely arose from previous H5 infection, while others may represent cross-reactivity with epitopes shared among H1, H3, and H5 viruses. The study also raises the interesting question of whether T-cell assays can be used as diagnostic tests for viral infections.

Powell, T., Fox, A., Peng, Y., Quynh Mai, L., Lien, V., Hang, N., Wang, L., Lee, L., Simmons, C., McMichael, A., Farrar, J., Askonas, B., Duong, T., Thai, P., Thu Yen, N., Rowland-Jones, S., Hien, N., Horby, P., & Dong, T. (2011). Identification of H5N1-Specific T-Cell Responses in a High-risk Cohort in Vietnam Indicates the Existence of Potential Asymptomatic Infections Journal of Infectious Diseases, 205 (1), 20-27 DOI: 10.1093/infdis/jir689
 
Re: Man Made H5N1 - Super Version

Statement on NSABB's March 30, 2012 Recommendations to NIH on H5N1 Research

April 14, 2012

On March 29-30, 2012, the National Science Advisory Board for Biosecurity (NSABB) was convened to examine two revised manuscripts regarding the transmissibility of the H5N1 avian flu virus in ferrets.

The NSABB is an independent federal advisory committee chartered to provide advice and guidance 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 regarding biosecurity oversight of dual use research, defined as biological research with legitimate scientific purpose that may be misused to pose a biologic threat to public health and/or national security.

After careful deliberation, the NSABB unanimously recommended that the revised manuscript submitted by Dr. Yoshihiro Kawaoka be communicated in full. The NSABB also recommended, in a 12-to-6 decision, that the data, methods, and conclusions presented in the revised manuscript submitted by Dr. Ron Fouchier be communicated after appropriate further scientific review and revision. A final recommendation of these two revised manuscripts regarding the transmissibility of the H5N1 avian flu virus in ferrets will be made by the HHS Secretary and brought to the broader U.S. government.

In addition, in their final recommendations submitted to NIH yesterday, the NSABB also made two other thoughtful recommendations about future approaches to the challenges presented by oversight of dual use research. Those recommendations are being carefully reviewed and considered. HHS will continue to work with scientific and national security experts, the public, and the international community regarding the long term recommendations on dual use research.

I want to take this occasion to express my sincere gratitude to the NSABB members, who have worked tirelessly to study the issue carefully, hear directly from the experts, and weigh the benefits and risks of making the research data public.

The full NSABB recommendations can be found at http://www.nih.gov/about/director/03302012_NSABB_Recommendations.pdf. (PDF - 268 KB)

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

http://www.nih.gov/about/director/04142012_NSABB.htm
 
Re: Man Made H5N1 - Super Version

Source: http://www.nature.com/news/mutant-flu-researcher-plans-to-publish-even-without-permission-1.10469

Nature | News
Mutant-flu researcher plans to publish even without permission

Virologist plans to defy Dutch government over export permit requirement for avian flu paper.

* Declan Butler

17 April 2012

Dutch authorities say work on an avian flu virus that is transmissible between mammals cannot be published without an export permit.


Ron Fouchier, a researcher at the Erasmus Medical Center in Rotterdam, the Netherlands, whose work on H5N1 avian flu virus has been at the centre of controversy, says that he is prepared to defy government demands and submit the work to Science without seeking the export permit that the Dutch government says is required.

A government official says that such an action could incur penalties including up to six years' imprisonment...
 
Re: Man Made H5N1 - Super Version

"could" ...

At the conference he said that the laws are at least unclear.
Some lawyers will think this way, the other lawyers will think the other way.
Parliament must decide ?!
 
Re: Man Made H5N1 - Super Version

with the seropositivity studies ... i'm wondering whether you can build
antibodies from dead viruses or viruses that fail to replicate in that
sort of cells.
Well, of course you can, we know it from vaccines -
but does it happen in nature ?
 
Re: Man Made H5N1 - Super Version

http://news.sciencemag.org/scienceinsider/Final Sensenbrenner H5N1 040912.pdf

ahh, the NSABB uses a risk assessment tool.

http://oba.od.nih.gov/biosecurity/pdf/Framework for transmittal 0807_sept07.pdf
62 pages .pdf, June 2007

does it envolve estimating the probability and damage expectation value of a H5N1 pandemic ?
I can't find it. Nor were those values given by Holdren or even hinted that they were
being estimated by experts and considered low enough.

http://oba.od.nih.gov/oba/biosecuri...or_Oversight_of_DURC_FINAL_version_032812.pdf
4 pages .pdf , no date given

> serious procedual and legal hurdles
(read: the functioning of US-bureaucracy here is more important than the H5N1-threat)

> ... would not immediately enable abuse
 
Re: Man Made H5N1 - Super Version

Source: http://app1.kuhf.org/articles/npr13...econsider-Restrictions-On-Bird-Flu-Study.html

Dutch Government Set To Reconsider Restrictions On Bird Flu Study
April 20, 2012
by: Nell Greenfieldboyce


A Dutch virologist is considering his full range of legal options if his government refuses to lift the restrictions it has put on his controversial bird flu research, and matters could quickly come to a head after a meeting next Monday that will be attended by U. S. observers...
 
Re: Man Made H5N1 - Super Version

Publication ban on virus research: security or censorship?

Published on : 21 April 2012 - 6:41pm | By Willemien Groot

On Monday, Dutch experts will debate whether or not Dr Ron Fouchier should be allowed to publish the results of his research, which has created a potentially dangerous strain of the H5N1 bird flu virus. The United States biosecurity watchdog has withdrawn its objections to publication. Dutch Deputy Minister for Innovation Henk Bleker, on the other hand, still fears the research could be used by terrorists. Fouchier rejects any ban on publication of his work. A row is in the making.

Deputy Minister Bleker has announced that he?s imposing a ban on publication ? in the journal, Science - of the research which was carried out at the Erasmus Medical Centre in Rotterdam. He cites the rules laid down in the government?s User Guide on Strategic Goods and Services on the export of sensitive information.

Censorship

Fouchier has yet to apply formally for an 'export licence' to publish his research findings, but the ministry has already said it will refuse the application. The researcher, however, now intends to offer the article for publication without it being seen by a review commission. He says the demand amounts to 'scientific censorship'. In an interview in the scientific journal Nature, he says he?s prepared to take the matter to court.

Minister Bleker?s gagging move has been greeted with surprise both in the Netherlands and abroad - despite initial misgivings, the US watchdog, the National Science Advisory Board for Biosecurity, has announced it has no problem with publication.

Some, however, understand the Dutch government?s tough stance.
Professor Ben Ale, an expert on security issues and disaster management, finds it perfectly reasonable that governments should give careful consideration to the publication of information on organisms or other things which could cause problems on a global scale. ?The researchers in this case acknowledge the mutated influenza virus could cause a pandemic. That seems to me worrying enough.?


More...
http://www.rnw.nl/english/article/publication-ban-virus-research-security-or-censorship
 
Re: Man Made H5N1 - Super Version

Dutch government will decide about an export permit after this meeting.


Description International Expert Meeting H5N1

Date and time of meeting Monday 23 April 2012

8h00 Read manuscripts on-site

10h00 Welcome and overview of the meeting
Ambassador Paul van den IJssel

10h10 Introductions

10h20 Presentation of H5N1 studies
Dr. Ron Fouchier, Professor of Virology, Erasmus Medical
Centre

11h00 Coffee break

Presentation of the H5N1 studies - continued

11h10 Dr. Yoshihiro Kawaoka, Professor of Virology, University
of Wisconsin-Madison

11h35 Dr. Derek Smith, Professor of Infectious Disease
Informatics, University of Cambridge

12h00 Presentation of the summary of WHO technical
consultations
Dr. Keiji Fukuda, Assistant Director-General for Health
Security and Environment

12h30 Presentation on non-proliferation aspects H5N1 research

13h00 Working lunch

14h00 Discussion on various aspects of H5N1 research

15h30 Coffee break

15h45 Discussion on various aspects of H5N1 research

17h30 Closing remarks by chair
Ambassador Paul van den IJssel

http://www.rijksoverheid.nl/ministe...de-expertbijeenkomst-vogelgrieponderzoek.html

See also (in Dutch):Kamerbrief over internationale expertbijeenkomst vogelgrieponderzoek
 
Re: Man Made H5N1 - Super Version

is it public ?
(--> live info from twitter or such)

10:20 Fouchier, 11:10 Kawaoka,11:35 Smith,12:00 Fukuda


Bleker interview in Dutch:

http://pauwenwitteman.vara.nl/Polit...]=1547&cHash=434da91293aa20225d064c122cc77d96

apparently no (natural-)scientific background:
1975 policy employee, on the ministry of home affairs.
1976 researcher at the legal factorial Groningen
1984-1999 interim manager and driver.
2009 director, at the regional broadcasting RTV North
1971-1977 training political economy
1984 test book , proportions between governments
 
Re: Man Made H5N1 - Super Version

> The Dutch government will resign on Monday in a crisis over budget cuts,
 
Re: Man Made H5N1 - Super Version

Congress Has More Questions About NSABB's H5N1 Decision

by David Malakoff on <ABBR class=published title="23 April 2012">23 April 2012, 2:12 PM</ABBR>

...
Representative Jim Sensenbrenner (R-WI) today sent a letter to Francis Collins, director of the National Institutes of Health (NIH), asking him to clarify how the National Science Advisory Board for Biosecurity (NSABB) reached its recent decision to recommend publication of the two studies after recommending against publication late last year. The letter also asks for more information on which government officials were involved in new rules for reviewing taxpayer-funded research that might be "dual use research of concern" (DURC).

"It appears that the Administration was unprepared for the possibility that the NSABB might recommend against publication, and then, caught on its heels, sought to avoid the recommendation," Sensenbrenner wrote. "If true, this response does little to prepare the United States government to better handle similar issues in the future. I am asking the NIH to clarify exactly where the new government policy guidelines came from and how they will be implemented."
...

Full text:
http://news.sciencemag.org/scienceinsider/2012/04/congress-has-more-questions-about.html?ref=hp
 
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