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PostPosted: Tue Apr 17, 2012 5:08 pm 
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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/03302 ... ations.pdf. (PDF - 268 KB)

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health
http://www.nih.gov/about/director/03302 ... ations.pdf

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PostPosted: Sat Apr 21, 2012 12:29 am 
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The United States government has formally accepted a recommendation from a biosecurity advisory board to publish two controversial studies of the H5N1 avian influenza virus, moving the pair of papers another step closer to publication.

The announcement came today in a statement from Francis S. Collins, director of the National Institutes of Health, which was posted on NIH's Web site. It says that Collins and Kathleen Sebelius, the secretary of the Department of Health and Human Services, "concur with the NSABB's [U.S. National Science Advisory Board for Biosecurity's] recommendation that the information in the two manuscripts should be communicated fully and we have conveyed our concurrence to the journals considering publication of the manuscripts. This information has clear value to national and international public health preparedness efforts and must be shared with those who are poised to realize the benefits of this research. … The Secretary's decision takes account of relevant U.S. law, international obligations, and a rigorous analysis of the benefits and risks of publication."

The announcement follows a 30 March announcement from the NSABB that it supported publication of revised versions of the two papers, one by Yoshihiro Kawaoka at the University of Wisconsin, Madison, and another by Ron Fouchier of Erasmus MC in the Netherlands. Late last year, the panel had recommended against full publication, concluding that the risks posed by the research outweighed its potential benefits. The decision sparked a global controversy and ultimately prompted NSABB to reconsider the decision.


Fouchier's paper still faces at least one hurdle to publication by Science. On 23 April, the Dutch Ministry of Foreign Affairs in The Hague is hosting a meeting to discuss the security implications of the H5N1 research. In particular, the Dutch government is deciding whether if it will invoke export-control laws in a bid to prevent Fouchier from submitting a revised version of his paper to Science.

The security implications of biomedical research are also expected to get some attention from U.S. lawmakers on 26 April, when the U.S. Senate Committee on Homeland Security and Governmental Affairs has scheduled a hearing on "Biological Security: The Risk of Dual-Use Research." Scheduled to testify are: Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which funded the two controversial flu studies; Daniel Gerstein, deputy under secretary for science and technology at the U.S. Department of Homeland Security; Paul Keim, acting chair of NSABB and a microbiologist at Northern Arizona University in Flagstaff; and Thomas Inglesby, director of the Center for Biosecurity at the University of Pittsburgh Medical Center in Pennsylvania.

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

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PostPosted: Sat Apr 21, 2012 7:57 pm 
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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.


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Fouchier's research

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Ron Fouchier and his colleagues studied whether the H5N1 virus could mutate into a strain which would be dangerously contagious for humans. At present, no such strain has occurred in nature. They produced a highly contagious strain which could be passed between ferrets. Theoretically, only a few steps would be needed to produce a similar virus which was life-threatening to humans. Fouchier’s research has resulted in his being given a place in the Time Magazine Top 100 of most influential people.

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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.”

Scientific research into viruses is a medical necessity. The work can, however, also aid the development of biological weapons. This dual use to which research can be put led in 2007 to the Royal Dutch Academy of Sciences (KNAW) drawing up a code of conduct in relation to biosecurity. The document considers the risks of scientific publications.
“The aim of the code of conduct is to make scientists aware of the possible risks, not to hinder their research,” explains Dr Koos van der Bruggen of Leiden University.

Dispute
Initially, the US biosecurity watchdog NSABB came out against publication, not only of the Dutch research but also of similar findings by a Japanese-US team of scientists. However, the researchers were not alone in resisting a ban: the World Health Organisation called for openness in the interests of combatting the virus. The problems appeared to have been resolved after the Rotterdam researchers submitted an adjusted version of their findings - that is, until the Dutch government came up with new objections.

Question of principle
A scientific publication has never before been blocked in this way in the Netherlands. Van der Bruggen:

“This is the result of the Netherlands not having the structure to ensure that a good decision prevails. In the US, the NSABB fulfils this function. There it’s possible to have open discussion, which actually means that an earlier decision can be rescinded.”

The government has invited civil servants, virologists and security specialists to debate the issue on Monday. “Hopefully, the outcome of the debate will offer Minister Bleker an elegant way out,” says Van der Bruggen.

He believes that fundamental scientific research is involved for which no export licence is needed. If the ban is upheld, it could have far-reaching consequences for other dual-use research. “This is a question of principle. I hope the minister won’t dodge the debate.”

http://www.rnw.nl/english/article/publi ... censorship

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PostPosted: Sun Apr 22, 2012 7:11 am 
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The Latest on the Doomsday Virus

Published: April 21, 2012
We can worry less that a newly created bird flu virus might kill tens or hundreds of millions of people if it escaped from the laboratory. But there is still some residual danger. And we remain appalled at the slipshod way in which this research was authorized despite its potential dangers to public health and national security.

The tale is a complicated one, but worth understanding since this is not the last time that this country and the world will face serious questions about scientific research and biosecurity. And government officials must ensure that, going forward, the process of approving such experiments works a lot more rationally.

The most worrying experiments were carried out by Dutch scientists and financed by this country’s National Institutes of Health. The researchers started with the bird flu virus, which seldom infects humans but is highly lethal when it does. With five mutations they made it transmissible through the air among ferrets and possibly humans.

Based on statements by the lead scientist that the virus retained its lethality, we urged in January that it be destroyed or studied only in a few high-containment laboratories, and that nothing be published about the experiments or, at a minimum, that details that might help a terrorist be redacted. In March, after the lead scientist, in a turnabout, said his new virus did not actually spread all that easily and was not lethal to ferrets when it did so, we called for clarification by an independent arbiter, like the National Science Advisory Board for Biosecurity. That is the group of nongovernmental experts that originally voted 22 to 0 to recommend that the paper be published only after details on specific mutations and how they were made were redacted.

Now that board has changed its mind. In late March, after reviewing a revised version of the paper and grilling the Dutch scientist, it voted 12 to 6 to recommend publication with none of the details excised.

Board members told us that the new virus appeared less lethal than they first thought; the benefits of letting scientists around the world keep an eye out for the specific mutations in nature appeared greater than they first thought; and the risk that a terrorist would use the information seemed minimal, judging from a briefing they got from intelligence officials. Many members also felt boxed in when federal officials said that redacting the details would harm America’s relations with nations that wanted full access.

The board’s new verdict is not wholly reassuring. The members had little time to digest a revised version of the Dutch paper and other new data, and they heard what the board’s leading influenza expert, Michael Osterholm, described in a letter to the National Institutes of Health and board members as a very “one-sided” presentation that was “designed” to push the board to reverse itself without hearing from independent experts with contrary views.

Even if the new virus is not highly lethal, board members say that might change should the virus escape confinement and recombine with other viruses to become both highly lethal and easily transmissible.

Federal officials say they know they must do better in the future. They recently issued a new policy that will require all federally financed experiments with bird flu and other worrisome pathogens to be evaluated for risks and benefits before they start. In this case, the danger of accidental release was weighed beforehand by Dutch review boards, and the laboratory was inspected by American experts. But the threat of a terrorist’s using the information to cause a pandemic was not formally assessed by anyone until after the experiments were done and papers had been submitted for publication.

The new policy will need to be monitored closely and buttressed with more detailed guidance to scientists and review groups on how to weigh the risks and benefits of experiments that might cause the greatest damage. Federal officials will also need to persuade other countries to conduct similar evaluations. The health of millions should not be left to luck.

http://www.nytimes.com/2012/04/22/opini ... ss&emc=rss

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PostPosted: Mon Apr 23, 2012 5:33 pm 
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Congress Has More Questions About NSABB's H5N1 Decision

by David Malakoff on 23 April 2012, 2:12 PM| 0 Comments

Round two. Sensenbrenner wants to know more about the government's response to H5N1 research controversy.

Credit: U.S. House of Representatives


A senior Republican in the U.S. House of Representatives is asking more questions about how the U.S. government reviewed two controversial H5N1 avian influenza studies, and how it wrote a new policy for reviewing taxpayer-funded studies that might be used for good and evil.

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."


Sensenbrenner's letter appears to have been prompted, in part, by complaints about the NSABB process outlined in a letter to NIH officials written earlier this month by one member of the panel, Michael Osterholm of the University of Minnesota, Twin Cities.

This isn't Sensennbrenner's first letter on the topic. On 1 March, the lawmaker—a former head of the House committees on science and the judiciary, and currently vice chair of the House Committee on Science, Space, and Technology—wrote to White House science adviser John Holdren , asking similar questions about how the Obama Administration has handled the H5N1 controversy. Holdren replied on 9 April.

The letter comes as a Senate panel prepares for a hearing later this week on how the U.S. government is handling biological research that could have dual use.

http://news.sciencemag.org/scienceinsid ... tml?ref=em

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PostPosted: Wed Apr 25, 2012 6:45 pm 
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Director Collins Comments on H5N1 Controversy

Wed, 04/25/2012 - 11:13am

On March 29 and 30, the National Science Advisory Board for Biosecurity (NSABB), an independent expert committee that advises the National Institutes of Health (NIH), the Department of Health and Human Services (HHS) and other Federal departments and agencies on matters of biosecurity, convened to review unpublished revised manuscripts describing NIH-funded research on the transmissibility of H5N1 influenza virus—the strain commonly referred to as "bird flu." One manuscript, “Aerosol transmission of avian influenza A/H5N1 virus,” contained research findings by Dr. Ron Fouchier. The other manuscript, “Haemagglutinin mutations that confer human-type receptor recognition and support respiratory droplet transmission of H5N1 influenza A virus in ferrets,” contained research findings by Dr. Yoshihiro Kawaoka. To clarify the results of their research findings, both authors revised their manuscripts from versions reviewed earlier by the NSABB. The NSABB reviewed the revised manuscripts to make recommendations as to whether, and if so how, they should be communicated.

This line of research is critically important because it will help public health officials understand, detect, and defend against the emergence of H5N1 virus as a human threat, a development that could pose a pandemic scenario. The value of this research notwithstanding, certain information obtained through such studies has the potential to be misused for harmful purposes—a characteristic associated with what is referred to as “dual use research of concern.” These particular manuscripts include the important finding that the H5N1 virus has greater potential than previously believed to gain the capacity to be transmitted among mammals, as assessed by experiments with ferrets. The manuscripts describe some of the genetic changes that appear to correlate with this potential.

During its March meeting, the NSABB took into account the new and clarified information in the manuscripts, additional perspectives provided by influenza biology experts, highly pertinent but as yet unpublished epidemiologic data, and relevant security information.

After careful deliberation, the NSABB unanimously recommended the revised manuscript 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 by Dr. Ron Fouchier be communicated fully after a number of further scientific clarifications are made in the manuscript. The recommendation to communicate the research was based on the observation that the information in the revised manuscripts has direct applicability to ongoing and future influenza surveillance efforts and does not appear to enable direct misuse of the research in ways that would endanger public health or national security.

The HHS Secretary and I concur with the NSABB’s recommendation that the information in the two manuscripts should be communicated fully and we have conveyed our concurrence to the journals considering publication of the manuscripts. This information has clear value to national and international public health preparedness efforts and must be shared with those who are poised to realize the benefits of this research.

The Secretary’s decision takes account of relevant U.S. law, international obligations, and a rigorous analysis of the benefits and risks of publication. The work in the Netherlands by Ron Fouchier is subject also to laws and regulations of the Netherlands, and the Dutch government is conducting its own review of Dr. Fouchier’s work. We respect that process and value the dialogue we have with Dutch authorities toward our common goals of encouraging scientific inquiry, advancing global health, and protecting the safety and security of our populations and the wider global community.

In addition, the recently released Federal policy on dual use research of concern is an important step in enhancing the oversight of federally funded life sciences research going forward. Through implementation of this policy, the U.S. Government aims to preserve the benefits of vitally important life sciences research that holds the promise of enhancing quality of life for all of us, while minimizing the possibility that the knowledge, information, products, or technologies provided by such research could be misused for harm.

I am grateful to the NSABB members for the time and effort they have dedicated to considering the complex issues pertinent to dual use research generally, and for working so tirelessly on developing the most thoughtful recommendations possible regarding these two manuscripts.

Date: April 20, 2012
Source: National Institutes of Health
http://www.dddmag.com/news/2012/04/dire ... ontroversy

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PostPosted: Tue May 01, 2012 6:23 pm 
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H1N1pdm09 recombination in H5N1 in Egypt confirmed.

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PostPosted: Fri May 11, 2012 10:29 am 
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H5N1 Transmission in Ferrets

By Amesh A. Adalja, MD, FACP, May 11, 2012



Fears of an impending H5N1 influenza pandemic have existed since the first cases of human infection appeared 15 years ago. A pandemic could occur only if the virus acquired mutations that made it more adept at transmission among humans. Two recent and controversial studies have raised the spectre of increased mammalian droplet transmissibility. Now, after prolonged international debate about the biosecurity concerns posed by these studies of genetically modified H5N1 influenza viruses, the first paper, by Yoshihiro Kawaoka and team, has been published by Nature (online, May 2, 2012).


Focus on HA Binding Domain


One of the factors that restricts the host range of H5N1 is the predilection of the viral hemagglutinin globular head to bind host sialic acid linked to galactose by an α2,3 linkage. The α2,3 linkage is found in avian species; the α2,6 linkage is found in mammals. Using the GeneMorph II kit and working in a BSL-2 containment setting, Kawaoka and colleagues introduced random mutations into the binding region of the HA gene in an H5N1 virus in which the polybasic HA cleavage sequence was removed. They recovered 370 viruses with a preference for the α2,6 linkages needed for optimal human adaptation and 9 isolates that were used for more detailed experimentation and characterization.



When the viruses where characterized, the induced mutations clustered around the binding pocket region of the HA molecule. Mutations known to confer human binding properties, including N186K, S227N, and Q226L, were present, along with new mutations not previously known to play a role in human binding. The researchers then subjected 8 of the 9 viruses to solid-phase binding assays in which one virus with strong α2,6 binding properties remained (1 of the 9 viruses reverted to wild type, leaving 8 for study). This remaining virus contained the following HA mutations: E119G, V152I, N224K, and Q226L. These mutations were then tested singly and in combination, revealing that the N224K/Q226L combination was responsible for the shift to α2,6 binding. This binding preference was confirmed in cell culture with human tracheal cells. The specific mutation N224K may alter the orientation of the 220-loop of the HA-receptor binding domain allowing a better interaction with the mutation at position 226 and α2,6 linked receptors.


Combination with 2009 H1N1



One way that an H5N1 pandemic may occur would be through reassortment with a seasonal influenza strain in an animal, such as a pig. When the 2009 H1N1 pandemic occurred, the fear of that occurrence became real. To test the possibility of a 2009 H1N1-H5N1 reassortment in a pig, the HA gene from the mutant H5N1 virus was combined with the remaining 7 genes of a 2009 H1N1 virus in a BSL-3+ setting approved by the CDC and USDA. The researchers generated 3 combination viruses that had the virulence-enhancing polybasic cleavage site intact. The viruses they created included one that had all 4 mutations, one that had only the N224K/Q226L combination mutation, and one with a wild type H5 HA.



Three ferrets were then infected with the virus via nasal inoculation. At day 3, both of the mutated recombinant viruses of interest showed diminished replicative ability in ferret tracheas. Nasal replication levels were similarly low with the quadruple mutant virus, but not with the dual mutant. By day 6, the virus with the N224K/Q226L mutation still showed high levels of nasal replication. When the dual mutant virus was isolated from 2 of the ferrets, the researchers observed a new mutation at site 158; that mutation caused the loss of glycosylation (a factor in tissue tropism) at the site.



Ferret Transmission Studies


To establish whether a reassorted H5/H1N1 virus could be transmitted between ferrets by respiratory droplets, inoculated caged ferrets were placed next to naïve caged ferrets. Of the viruses tested, the triple mutant (N158D/N224K/Q226L) virus was recovered from 2 of 6 contact ferrets. Seroconversion occurred in 5 of 6 ferrets. No ferrets suffered fatal infection. New mutations were identified in the transmitted viruses (K193N, A242S, T318I). Virus from the contact ferret that was shedding the highest titer contained the N158D, N224K, Q226L, and T138I mutations and was selected for further study. In transmission studies, this virus was isolated from 4 of 6 contact ferrets and caused all contact ferrets to seroconvert. No fatal infections occurred. In other experiments, the T318I mutation alone was not found to be sufficient for transmissibility or α2,6 binding, but it was found to stabilize the HA molecule with respect to pH-dependent fusion with host cells and heat stability.



Virulence and Vaccine Neutralization


To assess the virulence of the mutant virus (N158D/N224K/Q226L/T318I), the researchers compared it with 2009 H1N1 and found that the 2 groups of ferrets had no statistically significant difference in weight loss, and they had similar pathological changes in nasal passages. Each of the 3 reassorted viruses caused lung pathology.



To determine whether existing H5 influenza vaccines would protect against the mutant virus, sera from those vaccinated with the U.S.-licensed vaccine was tested against the virus and found to be neutralizing in HAI assays. The virus was also susceptible to oseltamivir.



Limited Applicability of Results



The discovery of mutations that confer respiratory transmissibility of an H5/H1 chimera virus in ferrets is important in that it expands understanding of basic influenza biology. However, it may be difficult, for a number of reasons, to use this data to make inferences about virus behavior in a natural setting. The researchers studied a combination virus that included 2009 H1N1 virus, which could have exerted an influence on mammalian transmissibility as strong as that of the 7 genes that came from H1N1, and especially PB2. Further, the pathway to an H5N1 pandemic may not require reassortment with H1N1.



Of the 4 mutations identified in this study, N158D, which caused loss of glycosylation, has already been observed in some areas, some of which also harbor the human-adapting mutation at site 627in PB2.Theoretically, identifying these mutations could aid influenza surveillance and allow the rate and locations at which these mutations are occurring in the wild to be assessed; however, widespread and timely sequence surveillance is not being conducted in most of the affected countries.



This study underscores the fact that in order to harness the full benefit from the knowledge gained by this study, an augmented surveillance capacity is needed.

Reference

Imami M, Watanabe T, Hatta M, et al. Experimental adaptation of an influenza H5 HA confers respiratory droplet transmission to a reassortant H5 HA/H1N1 virus in ferrets. Nature 2012. http://www.nature.com/nature/journal/va ... 10831.html. Accessed May 7, 2012.

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PostPosted: Sat May 12, 2012 8:30 pm 
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Science journal could give recipe for deadly avian flu virus


By Libby Lewis, CNN Radio

updated 6:25 PM EDT, Sat May 12, 2012
Image

CNN) -- A science journal is poised to publish a study that some experts believe could give a recipe to bioterrorists.

The study is from an experiment by a Dutch scientist who engineered the avian flu virus to make it more deadly to mammals by making it spread through the air.

That experiment was funded by the U.S. government, and it has sparked a passionate debate among scientists. Part of that debate is over where this research could lead, and whether it is worth it.

The National Institutes of Health and some scientists say it is worth it. They say it could ultimately protect mankind by trying to anticipate how the virus could mutate to one that causes a pandemic -- like the one in the film "Contagion."

Dr. Anthony Fauci heads the NIH agency that funds infectious diseases research. It funded the controversial Dutch experiment.

"We need as scientists and health officials to stay one step ahead of the virus as it mutates and changes its capability," Fauci told CNN Radio recently. "To anticipate that would be important to determine whether the countermeasures we have available, such as antivirals and vaccines, would actually be effective against such a virus that changed in such a way."



But a number of scientists are stepping forward to say it is not worth it -- and that this research could actually bring us closer to that nightmare.

CNN Radio's Libby Lewis reports on the controversial research

How? By making a lethal virus that spreads like seasonal flu.

"We are playing with fire," says Dr. Thomas Inglesby and his colleagues at the Center for Biosecurity at the University of Pittsburgh Medical Center.

If this engineered virus were to escape the laboratory, by accident or by evil, "it could endanger the lives of hundreds of millions of persons," Inglesby says.

The journal Science is now reviewing the manuscript by Dutch scientist Ron Fouchier, a virologist at the Erasmus Medical Center in the Netherlands.

In December, the National Scientific Advisory Board for Biosecurity warned against publishing Fouchier's study and a similar study from Wisconsin. The Wisconsin study was based on a similar experiment but used a less lethal strain of the virus.

In March, that same advisory board looked at revised versions and said the Wisconsin study was safe to publish. But some on the panel broke ranks on publishing Fouchier's work. Twelve said yes; six said no.

Michael Osterholm, an infectious diseases expert at the University of Minnesota, was one of the six "no" votes on the board. In a letter to NIH after the vote, Osterholm described the studies as "nearly a complete cookbook" for those who would do harm.

The journal Nature just published the Wisconsin study. The journal Science is expected to publish Ron Fouchier's study within weeks.

NIH: OK to publish controversial bird flu studies

Here's what you need to know about the avian flu research:

Is the engineered avian flu virus as easily spread between people, as well as animals?

It's not certain. But evidence shows it's likely to spread the same way between people as it does between the ferrets that Fouchier used in his experiment.

Why did the government fund this research if it's so risky?

They wanted to know why avian flu spreads so fast among birds but not among people. People only catch bird flu if in they're in close contact with infected birds.

Here, the government funded two studies, one led by Fouchier and the other by Wisconsin flu researcher Yoshi Kawaoka. Both used genetic engineering to explore which mutations might turn an avian flu into one that could spread easily between people.

The NIH says these experiments show that it's possible for the bird flu virus to evolve to a highly transmissible killer virus like the one in "Contagion."

"These studies raised the red flag," said Robert Webster, a virologist and flu researcher at St. Jude Children's Research Hospital. "The cat's out of the bag."

Well, now what?

These experiments lay a path to a whole new area of genetic engineering in flu research.

The government and supporters of the controversial experiments say more research will lead to a better understanding of the genetic mutations that could lead to a viral pandemic.

But other scientists say this is the wrong road to take.

Sir Richard Roberts, a molecular biologist who's won the Nobel Prize, spoke out at a recent National Academies workshop on the bird flu experiments.

"Someone is trying to make the most dangerous virus we can think of," Roberts said. "I don't understand how one can justify that, unless there is no other way of getting the data that you're interested in.

"And the way you get data is surveillance, and to see what is going on in nature, and to respond to it accordingly. And you go out of your way to find a universal vaccine. I would much sooner see money spent on that than on creating the most dangerous virus imaginable. I find it indefensible."

Roger Brent, a biologist at the Fred Hutchinson Cancer Research Center in Seattle, said he believes these experiments create more danger than benefit.

Brent told CNN that in order to be valuable -- that is, to reliably show the ways that bird flu could evolve to infect humans -- these experiments would require more experiments that could generate recipes for more, and different, man-made viruses -- all of them dangerous.

"Scientists must ask: Do we really want to do these experiments?" Brent said. "If we're generating knowledge that we feel dodgy about, do we really want to generate 20 or 100 additional (engineered viruses) that create something that most people would believe to be bad?"

Is the government going to fund more of this research?

Possibly. The controversy over the Fouchier experiment led to a temporary "voluntary moratorium" by flu researchers on genetic engineering.

It also prompted the U.S. government to begin crafting a policy on how to deal with "dual use" research like this that can lead to harm, as well as good.

At a recent hearing on the bird flu virus research, Sen. Joe Lierberman, I-Connecticut, asked Fauci whether he thought there were any experiments that should not be done.

Yes, Fauci replied, but he said he thought that would be rare.

Supporters of the Fouchier experiment say the results make the case for more support and funding.

At the National Academies workshop, one journalist said he had talked to a number of scientists who questioned the value of these experiments and where they could lead.

Flu researcher Robert Webster replied by saying the experiments brought bird flu back into the research conversation.

"Concern for bird flu had dropped. Really, H5N1 had disappeared from the radar screen. This shows it can occur. So we have to maintain pandemic preparedness."

http://articles.cnn.com/2012-05-12/us/u ... r?_s=PM:US

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PostPosted: Sat May 12, 2012 8:52 pm 
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Joined: Wed Aug 19, 2009 10:42 am
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Location: Pittsburgh, PA USA
niman wrote:
Science journal could give recipe for deadly avian flu virus



Michael Osterholm, an infectious diseases expert at the University of Minnesota, was one of the six "no" votes on the board. In a letter to NIH after the vote, Osterholm described the studies as "nearly a complete cookbook" for those who would do harm.


More media myth on H5N1 cookbook nonsense. The CDC paper published in early November in Virology (published BEFORE the first NSABB request), and the recent Kawaoka paper in Nature give FULL cookbook recipes for creation of transmitting H5N1.

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