BIO-PSYOP

BIOTERRORBIBLE.COM: In December of 2011, a global bio-terror PSYOP (psychological operation), hoax, or false-flag was executed when it was revealed that a mutated airborne form of the H5N1 strain of avian influenza was created by a Dutch team of scientists led by Ron Fouchier, of Rotterdam's Erasmus Medical Centre. This major discovery was fabricated in a calculated attempt by the U.S. government and the modern medical establishment to convince the world that humanity is on the precipice of a natural and deadly pandemic.

After the story made global headlines and a 60 day moratorium on flu research was called, the claim of the new deadly air-borne pathogens was all but retracted by the Dutch scientist who first broke the story. The overall goal of this operation was to prepare the public and the medical establishment for coming man-made pandemic that will materialize in reality sometime in the near future.

Access "Pause on Avian Flu Transmission Research " PDF at bottom of page:

Title: Novel Flu Cases Prompt New CDC Guidance
Date: December 18, 2011
Source: CIDRAP

Abstract:
Alongside last week's confirmation of another novel flu infection with an H3N2 variant, the US Centers for Disease Control and Prevention (CDC) launched a series of documents to advise health and lab workers on how to identify and report new cases.

On Dec 23 the CDC confirmed two more novel flu infections, including in a West Virginia child with a swine-origin H3N2 reassortant strain (H3N2v) that includes the M gene from the 2009 H1N1 virus. The youngster was a daycare contact of an H3N2v case reported on Dec 9, and the newly confirmed case pushed the nation's H3N2v total to 12 so far.

The other novel flu infection involved a swine-origin H1N1 variant (H1N1v) that had also acquired the M gene from the 2009 H1N1 virus. The CDC said the patient, an adult from Wisconsin who had occupational exposure to swine, was the first detection of the H1N1v strain in a human.

On the same day the CDC announced the two novel flu cases, it released documents that address preventing seasonal and H3N2v in healthcare settings, interim guidance on H3N2v specimen collection and testing, and interim case definitions for investigating H3N2v infections.

Most H3N2v infections have been mild, and only 3 of the 12 patients were hospitalized, the CDC said. Though it's not clear if cases will become more common, it's possible that healthcare providers will care for patients who have H3N2v infections, it added.

So far there is no evidence that H3N2v transmission characteristics are different from seasonal flu, so the CDC advises that facilities use the same infection control procedures as for seasonal flu to help guard against the spread of H3N2v, including the vaccination of healthcare workers. However, it added that the seasonal flu vaccine may provide limited protection against H3N2v in adults and no protection in children.

Given that limited person-to-person spread of H3N2v seems to be occurring, especially in children, the CDC released interim guidance designed to streamline its detection and investigation. It advised state and local health departments to use the CDC's real-time reverse transcriptase polymerase chain reaction (rRT-PCR) panel to screen for influenza A, influenza B, and ribonuclease P (an indicator of specimen adequacy), then use its influenza A subtyping kit, employing all primer and probe sets.

The CDC recommended that states increase the collection of respiratory specimens from patients with flulike illnesses who fall into certain high-priority groups, including children in childcare and school settings, unusual or severe flulike illness presentations (especially in kids), and medically attended flulike illnesses and acute respiratory infections in children.

Interim recommendations for collecting respiratory specimens for patients with suspected H3N2v infections are consistent with those for seasonal flu, the CDC said. It added that the duration of H3N2v shedding is unknown, and until more data are available, infected patients should be assumed to be contagious for up to 7 days from illness onset.

It said molecular assays may detect novel influenza A viruses but will not differentiate them from seasonal strains and may give an unsubtypable result, which should be forwarded to state or local labs for additional testing. Molecular assays may give a false-positive result for human H3 viruses, according to the CDC.

Rapid and immunofluorecense tests have unknown sensitivity and specificity to the H3N2v virus, and negative results from either test don't rule out flu infections in patients with signs and symptoms that suggest influenza.

The CDC said H3N2v viruses will be positive for the nucleoprotein (NP) gene (pdmInfA), influenza A, and seasonal influenza A (H3) targets of the CDC's rRT-PCR diagnostic panel. All suspected novel influenza A and H3N2v samples should be sent to the CDC for confirmational testing, it said. "Confirmation of influenza A (H3N2)v virus is performed only at CDC at this time."

The agency urged health departments to conduct contact tracing of confirmed, probable, or suspected H3N2v cases and provided definitions for the three levels of cases in a separate document. It asked health departments to notify the CDC about all suspected and probable H3N2v infections within 24 hours of identification.

The CDC defined a suspected H3N2v case as an acute respiratory illness in a patient who has an epidemiologic link to a confirmed case or got sick within 7 days of swine exposure.

It said a probable case is in a patient whose respiratory sample tested positive on the CDC RT-PCR flu panel for influenza A, pandemic influenza A, and H3, but negative for influenza B, pandemic H1, and H1. Also, a probable case could be in a person who has an acute respiratory infection and a link to a confirmed H3N2v case and whose diagnostic test is positive for influenza A (H3) or influenza A (no subtype tested or detected).

In a related development, the CDC updated its background information on swine influenza for pork producers and farmers, incorporating the latest information about novel influenza A viruses, urging people to take precautions when pigs and animal handlers have respiratory illnesses (CIDRAP, 2011)

Title: US: Don't Publish Lab-Bred Bird Flu Recipe
Date: December 20, 2011
Source:
MSNBC

Abstract: The U.S. government asked scientists Tuesday not to reveal all the details of how to make a version of the deadly bird flu that they created in labs in the U.S. and Europe.

The lab-bred virus, being kept under high security, appears to spread more easily among mammals. That's fueled worry that publishing a blueprint could aid terrorists in creating a biological weapon, the National Institutes of Health said.

But the NIH said it was important for the overall findings to be published in scientific journals, because they suggest it may be easier than previously thought for bird flu to mutate on its own and become a greater threat.

"It's very important research," NIH science policy director Dr. Amy Patterson told The Associated Press. "As this virus evolves in nature, we want to be able to rapidly detect . . . mutations that may indicate that the virus is getting closer to a form that could cross species lines more readily."

Bird flu, known formally as H5N1 avian influenza, occasionally infects people who have close contact with infected poultry, particularly in parts of Asia. It is highly deadly when it does infect people because it's different from typical human flu bugs. The concern is that one day it may begin spreading easily between people.

The NIH paid for two research projects, at the Erasmus University Medical Center in the Netherlands and at the University of Wisconsin, to better understand what might fuel the virus' ability to spread. The NIH said researchers genetically engineered bird flu that could spread easily among ferrets — animals whose response to influenza is similar to humans.

So the government's biosecurity advisers — the National Science Advisory Board for Biosecurity — reviewed the research as it was submitted to two scientific journals, Science and Nature. Following the board's recommendation, the Department of Health and Human Services asked the researchers and journal editors not publish the full genetic information that could enable someone to copy the work.

Patterson said publishing the general findings, however, could help scientists better monitor bird flu's natural evolution and spur further research into new treatments. The government will set up a way for scientists who are pursuing such work to be given the unpublished genetic details, she said.

Patterson said researchers were making changes in their scientific reports.

But in a statement, Science editor-in-chief Dr. Bruce Alberts said his journal "has concerns about withholding potentially important public health information from responsible influenza researchers" and was evaluating how best to proceed.

Nature's editor-in-chief, Dr. Philip Campbell, called the recommendations unprecedented.

"It is essential for public health that the full details of any scientific analysis of flu viruses be available to researchers," he said in a statement. The journal is discussing how "appropriate access to the scientific methods and data could be enabled" (MSNBC, 2011).

Title: U.S. Bio-Security Officials Sound Warning After Scientists Create Deadly New Strain Of Bird Flu
Date:
December 20, 2011
Source:
Fox News

Abstract: The U.S. government is sounding the alarm after reports that Dutch scientists have created a highly-contagious and deadly airborne strain of bird flu that is potentially capable of killing millions, The Independent reported Tuesday.

The U.S. National Science Advisory Board for Biosecurity is currently analyzing how much of the scientists' information should be allowed to be published—given the inherent risks of having the information fall into the hands of terrorists or rogue states.

"The fear is that if you create something this deadly and it goes into a global pandemic, the mortality and cost to the world could be massive," a senior US government adviser told The Independent.

Scientists, too, are questioning whether the science should ever have been performed in the first place.

"There are people who say that the work should never have been done, or if it was done it should have been done in a setting where the information could be better controlled," a source close to the US biosecurity board told the newspaper.

"With influenza now it is possible to reverse engineer the virus. It's pretty common technology in many parts of the world. With the genomic sequence, you can reconstruct it. That's where the information is dangerous."

The mutated form of the H5N1 strain of avian influenza was created by a Dutch team of scientists led by Ron Fouchier, of Rotterdam's Erasmus Medical Centre, and the researchers are now hoping to publish the details of how they developed the new strain.

The new virus differs from H5N1—which is only known to be transmitted between humans who have very close contact with each other—because it can be transmitted through the air in coughs and sneezes.

Fouchier, who declined to answer The Independent's questions, said in a statement that it only took a small number of mutations to change the avian flu virus.

"We have discovered that this is indeed possible, and more easily than previously thought. In the laboratory, it was possible to change H5N1 into an aerosol-transmissible virus that can easily be rapidly spread through the air," he said (Fox News, 2011).

Title: Alarm As Dutch Lab Creates Highly Contagious Killer Flu
Date:
December 20, 2011
Source:
The Indepenent

Abstract: A deadly strain of bird flu with the potential to infect and kill millions of people has been created in a laboratory by European scientists – who now want to publish full details of how they did it.

The discovery has prompted fears within the US Government that the knowledge will fall into the hands of terrorists wanting to use it as a bio-weapon of mass destruction.

Some scientists are questioning whether the research should ever have been undertaken in a university laboratory, instead of at a military facility.

The US Government is now taking advice on whether the information is too dangerous to be published.

To see the graphic: The last outbreak - A deadly virus even before the latest twist

"The fear is that if you create something this deadly and it goes into a global pandemic, the mortality and cost to the world could be massive," a senior scientific adviser to the US Government told The Independent, speaking on condition of anonymity.

"The worst-case scenario here is worse than anything you can imagine."

For the first time the researchers have been able to mutate the H5N1 strain of avian influenza so that it can be transmitted easily through the air in coughs and sneezes. Until now, it was thought that H5N1 bird flu could only be transmitted between humans via very close physical contact.

Dutch scientists carried out the controversial research to discover how easy it was to genetically mutate H5N1 into a highly infectious "airborne" strain of human flu. They believe that the knowledge gained will be vital for the development of new vaccines and drugs.

But critics say the scientists have endangered the world by creating a highly dangerous form of flu which could escape from the laboratory – as well as opening a Pandora's box for fanatical terrorists wishing to make a bio-weapon.

The H5N1 strain of avian influenza has killed hundreds of millions of birds since it first appeared in 1996, but has so far infected only about 600 people who came into direct contact with infected poultry.

What makes H5N1 so dangerous, though, is that it has killed about 60 per cent of those it has infected, making it one of the most lethal known forms of influenza in modern history – a deadliness moderated only by its inability (so far) to spread easily through airborne water droplets.

Scientists are in little doubt that the newly created strain of H5N1 – resulting from just five mutations in two key genes – has the potential to cause a devastating human pandemic that could kill tens of millions of people. The study was carried out on ferrets, which when infected with influenza are the best animal "model" of the human disease.

The details of the study are so sensitive that they are being scrutinised by the US Government's own National Science Advisory Board for Biosecurity, which is understood to have advised American officials that key parts of the scientific paper should be redacted to prevent terrorists from using the information to reverse-engineer their own lethal strain of flu virus.

In an unprecedented move, the Biosecurity board is believed to have told the US Government that there is a serious possibility of potentially dangerous information being misused if the full genetic sequence of the mutated H5N1 virus were to be published in open scientific literature.

A senior source close to the Biosecurity board, who wished to remain anonymous, told The Independent that the National Institutes of Health, which funded the work, is about to make a decision on how much of the scientific paper on the H5N1 super strain should be published, and how much held back.

"There are areas of science where information needs to be controlled," the scientist said. "The most extreme examples are, for instance, how to make a nuclear weapon or any weapon that is going to be used primarily to kill people. The life sciences really haven't encountered this situation before. It's really a new age."

The study was carried out by a Dutch team of scientists led by Ron Fouchier of the Erasmus Medical Centre in Rotterdam, where the mutated virus is stored under lock and key, but without armed guards, in a basement building.

Dr Fouchier, who declined to answer questions until a decision is made on publication, said in a statement released on the university's website that it only took a small number of mutations to change the avian flu virus into a form that could spread more easily between humans.

"We have discovered that this is indeed possible, and more easily than previously thought. In the laboratory, it was possible to change H5N1 into an aerosol-transmissible virus that can easily be rapidly spread through the air," Dr Fouchier said. "This process could also take place in a natural setting.

"We know which mutation to watch for in the case of an outbreak and we can then stop the outbreak before it is too late. Furthermore, the finding will help in the timely development of vaccinations and medication."

A second, independent team of researchers led by Yoshihiro Kawaoka of the universities of Wisconsin and Tokyo is understood to have carried out similar work with similar results, which has underlined how easy it is to create the super virus with a combination of deliberate mutations and random genetic changes brought about by passing avian flu manually from the nose of one ferret to another.

Some scientists have privately questioned whether such research should have been done in a university department that does not have the sophisticated anti-terrorist security of a military facility. They also point out that experimental viruses kept in seemingly secure laboratories have escaped in the past to cause human epidemics – such as a 1977 flu outbreak.

"There are people who say that the work should never have been done, or if it was done it should have been done in a setting where the information could be better controlled," said the source close to the biosecurity board.

"With influenza now it is possible to reverse engineer the virus. It's pretty common technology in many parts of the world. With the genomic sequence, you can reconstruct it. That's where the information is dangerous," he said.

"It's scary from a number of different angles. You want to have the vaccines and therapeutics in place, and you need to have a much information as you can about a particular virus, but you also worry about it from a biosecurity perspective."

Profile: Researcher behind the Science

Ron Fouchier

The Dutch virologist started as an expert in HIV, having received his PhD from the University of Amsterdam in 1995. After research at the University of Pennsylvania School of Medicine, he began a new career in the virology department at Erasmus Medical Centre in Rotterdam, studying the molecular biology of the influenza A virus.

At a conference in Malta in September, he described his work as something that was "really, really stupid," but ultimately useful for the development of vaccines (The Independent, 2011).

Title: Bird Flu Bioterror Risk Seen Increased By Censorship
Date: December 21, 2011
Source: Reuters 

Abstract: Any number of laboratories worldwide could engineer bird flu viruses into bioterror weapons capable of causing a human pandemic, and U.S. government efforts to censor research might only increase the risk that rogue elements may give it a try.

Experts say an unprecedented request by the U.S. National Science Advisory Board for Biosecurity (NSABB) for two leading scientific journals to withhold details of research into H5N1 bird flu is unlikely to block anyone already intent on evil.

 Yet ironically, the fact that the potential for H5N1 to be deliberately engineered into a highly pathogenic form has become headline news might put fresh thoughts into the wrong minds.

"Anything like this has the potential to trigger ideas in some maverick," said Peter Openshaw, director of the centre for respiratory infection and Britain's Imperial College.

"There are many crazy people out there, and there are also people who are fixed on some idea at the extreme end of the political norm. Both groups have the potential to cause harm."

H5N1 bird flu is extremely deadly in people who are directly exposed to it from infected birds.

Since the virus was first detected in 1997, about 600 people have contracted it and more than half of them have died. But so far it has not mutated into a form that can pass easily from person to person.

Scientists around the world have been working for many years trying to figure out which mutations would give H5N1 the ability to spread easily from one person to another, while at the same time maintaining its deadly properties.

Title: Bioterrorism Fears Spark Censorship Call
Date: December 22, 2011
Source: SMH


Abstract: 
The US government has asked the publishers of Nature and Science magazines to censor details on a laboratory-made version of the deadly bird flu virus for fear that the information could be used as a biological weapon.

Scientists seeking to fight future pandemics have created a variety of the H5N1 virus that is so dangerous that the US National Science Advisory Board for Biosecurity has for the first time asked two science journals to hold back on publishing details of research.

The editors at Science are taking the request of the advisory board seriously, said the journal's editor-in-chief, Bruce Alberts. They are trying to balance the need for other researchers to have detailed information against possible threats, he said in a statement.

''Science editors will be evaluating how best to proceed,'' Mr Alberts said.

Responses are contingent on the government developing a plan so that withheld information can be provided to researchers who request it ''as part of their legitimate efforts to improve public health and safety'', he said.

In the experiments, university scientists in the Netherlands and Wisconsin created a version of the H5N1 influenza virus that is highly lethal and easily transmissible between ferrets, the lab animals that most closely mirror human beings in flu research.

Members of the National Science Advisory Board for Biosecurity, which was created after the anthrax bioterrorism attacks of 2001, worried that such a hazardous strain might be intentionally or accidentally released into the world if directions for making it were generally known.

The board advises the US Department of Health and Human Services, which agreed with the non-binding recommendation.

After weeks of reviewing papers describing the research, the board said it had recommended that the experiments' ''general conclusions'' be published but not ''details that could enable replication of the experiments by those who would seek to do harm''.

''Censorship is considered the ultimate sin of original research. However, we also have an imperative to keep certain research out of the hands of individuals who could use it for nefarious purposes,'' said Michael Osterholm, a member of the board who is also the director of the Centre for Infectious Disease Research and Policy at the University of Minnesota. ''It is not unexpected that these two things would clash in this very special situation.''

The board cannot stop publication. Its advice went to the Department of Health and Human Services, whose leaders asked the authors of the papers and the journals reviewing them - Science, published in Washington, and Nature, published in London - to comply.

The journals' responses to the request were initially very chilly.

Reuters reported that the journals objected to the request, although later reports suggested they were willing to go along with it under certain conditions.

Dutch researchers said they ''are currently working on a new manuscript that complies with the recommendation''. The scientists at the University of Wisconsin could not be reached.

About 600 people, mostly in south-east Asia, have become ill from the H5N1 virus since 1997. About 60 per cent have died. The virus is rarely passed from person to person, more likely to occur with close contact with sick birds.

Because of its extreme virulence, H5N1 has been the flu strain most feared as the source of a possible influenza pandemic.

What it lacked were the genetic changes permitting easy transmission by coughing, sneezing and touch. The new research has produced those changes for the first time, at least in ferrets.

Exactly how the key new mutations occurred is unclear, although it seems in part to be the product of chance. Influenza viruses are constantly changing in small ways, which is one of the reasons vaccines against them have to be reformulated every few years. Infecting ferrets enough times with the virus may have been sufficient to allow mutations favouring easy transmissibility to emerge by chance and then be ''saved'' by natural selection (SMH, 2011).

Title: Too Late To Contain Killer Flu Science, Say Experts
Date:
December 22, 2011
Source:
The Independent

Abstract: Attempts to censor details of controversial influenza experiments that created a highly infectious form of bird-flu virus are unlikely to stop the information from leaking out, according to scientists familiar with the research.

The US Government has asked the editors of two scientific journals to refrain from publishing key parts of research on the H5N1 strain of bird-flu in order to prevent the information falling into the hands of terrorists intent on recreating the same flu strain for use as a bioweapon.

However, scientists yesterday condemned the move. Some said that the decision comes too late because the information has already been shared widely among flu researchers, while others argued that the move could obstruct attempts to find new vaccines and drugs against an infectious form of human H5N1 if it appeared naturally.

Professor Richard Ebright, a molecular biologist at Rutgers University in Piscataway, New Jersey, said that the research, which was funded by the US Government, should never have been done without first assessing the risks and benefits.

“The work posed risks that outweighed benefits and that were clearly foreseeable before the work was performed,” Professor Ebright said.

“The work should have been reviewed at the national or international level before being performed, and should have been restricted at a national or international level before being performed,” he said.

Two teams of researchers, one led by Ron Fouchier of Erasmus Medical Centre in Rotterdam and the other by Yoshihiro Kawaoke of  the University of Wisconsin-Madison, have submitted manuscripts on bird-flu virus to the journals Nature and Science. In them, they describe how they deliberately mutated the H5N1 strain of bird-flu into an “airborne” strain that can be transmitted in coughs and sneezes between laboratory ferrets, the best animal “model” of human flu.

In an unprecedented move, the US National Institutes of Health (NIH), which funded both projects, requested the deletion of key details of the methodology and viral genetic sequences from the manuscripts prior to publication. It did so following recommendations of its own independent advisers on the US National Science Advisory Board for Biosecurity.

Professor Paul Keim, chairman of the biosecurity board, said that the request to withhold certain details of the research is not the same as censorship and, although it sets a precedent in the biological sciences, it is common in other areas of science where there is potential for dual use of research in both civil and military applications.

“The US Government doesn’t have the legal authority to stop these publications. They have requested that the journals and scientists refrain from publishing the full details of their work, at this time,” Professor Keim said.

“It is hard to call that censorship. If the data and methods are restricted by the authors and journals, it is a voluntary action on their part. I also think that it is the responsible action for the current situation, and so does the US Government,” he said.

However, Dr Fouchier at the Erasmus Medical Centre in Rotterdam said that although his institute has agreed to abide by the voluntary restrictions on publication, he said it will be almost impossible to guarantee the confidentiality of the information given that the scientific data has already been shared with hundreds of researchers and governments in open scientific meetings.

Flu scientists in Britain, meanwhile, said that it is doubtful whether the details of the two experiments can be kept secret even if Science and Nature agree to the redaction of key parts of the scientific manuscripts – which they seem to have accepted.

“The exact mutations that made this transformation possible were not particularly novel or unexpected so anyone with a reasonable knowledge of influenza virology could probably guess at them if they so wished,” said Wendy Barclay, professor of influenza virology at Imperial College London.

“I’m very wary that information should be withheld from the scientific literature because we move forward by sharing information. It’s important to know if viruses such as H5N1 are capable of tolerating the mutations that would allow human-to-human transmission,” Professor Barclay said.

“We need to know the mutations to look our for. If we don’t know what the mutations are that make the virus more transmissible, we won’t know what to look out for when we monitor the spread of new flu viruses. This type of information is generated for a good reason – it’s to help us to be prepared,” she said.

Professor John Oxford, a flu expert at Queen Mary University of London, agreed: “The study by Fouchier is a huge service to all of us because it reminds us of how wafer thin the barrier is between a benign H5N1 virus and one that could spread easily. The 120 WHO flu labs around the world can use the DNA sequence information to identify and stop the spread of new H5N1 variants” (The Independent, 2011)

Title: Should Scientists Create Deadly Viruses? Yes, Says Bioethicist
Date: December 27, 2011
Source:
MSNBC

Abstract: One of the predictable consequences of science’s rapidly growing knowledge of genetics is that the knowledge can be put to use to kill, harm or terrorize. Controlling dangerous knowledge is not easy and rarely foolproof—just look at the history of successful spying to get the secrets to make nuclear weapons or crack secret codes. The ability to make a new nasty class of biological weapons that could be used against us raises two important questions — should scientists try to make dangerous microbes and, if they do, who should they tell about their work?

Recently, scientists working for the U.S. government made a deadly flu virus, H5N1, even more contagious by making it airborne. In its natural form, H5N1 kills more than half the people it infects, but almost never spreads from person to person. The new modified strain changes that. Last week, there was a kerfuffle when government advisers asked the details be kept secret and not published in scientific journals to keep the information from falling into the wrong hands.

The scientists who tweaked the H5N1 virus say their work was necessary because they had to see if it was possible for the virus to mutate – and if it was, so that countries could take more dramatic steps to eradicate it, reported the New York Times.

But others say it should never have been created in the first place, it’s too dangerous and could get out of the lab and into the population. So should scientists even be studying or making nasty microbial critters? The answer is yes. The only way to anticipate and respond to changes in nature that convert a relatively harmless strain of flu to a pandemic killer or to figure out ways to deal with horrors like flesh eating bacteria is to create and study them.

The second question becomes the key one—who should have access to this knowledge?

We need to do all we can to keep dangerous information out of the hands of both the bad and the irresponsible guys. This means not publishing the full formula for lethal microbes. It also means keeping an eye on where biological samples are shipped, who is invited to study at key laboratories and teaching ethical responsibility over and over again to budding scientists. It also means issuing government guidelines that journals, publishers, website managers and meeting organizers can follow to restrict what is made public that is obviously dangerous.

Some will sneer and say censorship has absolutely no place in science. But given the ways in which patents and trade secrets shape who has access to findings and data, that view is simply naïve. Others will say once the government starts dictating who can know what, the slope gets very slippery. But, the government should not make the rules — scientists, in consultation with other experts, should.

Some say no restrictions will work—information always gets out in the end. But we don't have to make the end easy to reach.  The dangerous uses of genetic knowledge should be kept as restricted as we can make them (MSNBC, 2011).

Title: Should Medical Journals Print Info That Could Help Bioterrorists?
Date: December 27, 2011
Source:
TIME

Abstract: Bird flu is deadly, but it generally does not spread easily from human to human. Now, scientists in Wisconsin and the Netherlands have created a strain of bird flu that can spread through the air — a virus that could kill millions if terrorists managed to create a batch and weaponize it. This raises a thorny question: Should medical journals be allowed to print the details of how the virus is made?

A government advisory board has urged two scientific journals to omit some of the specifics about the virus — the first time it has issued such a request. Supporters insist that the board’s request is a much-needed precaution that could save millions of lives. But critics say that the government is engaging in censorship and interfering with academic freedom.

It is a classic clash of liberty versus security. The question is such a difficult one because whichever course the government takes carries risks and costs. Which option — blocking publication or allowing it — is the lesser of two evils?

It is not hard to see why the government is seeking to keep details of the virus out of print. The H5N1 bird-flu virus rarely infects humans. But when it does cross the species barrier, the mortality rate can be as high as 60%. If terrorists were able to use the new research to make a contagious strain of the virus, the result could be a real-world version of the movie Contagion. That is: worldwide panic and mass deaths.

The government is trying to avoid this by urging scientific journals to describe the virus only in general terms and keep out the sort of details that could be used to replicate it. The National Science Advisory Board for Biosecurity, which was created after the deadly anthrax attacks of 2001, asked the journals Science and Nature to be selective when they published articles on the highly contagious strain of H5N1.

So what’s the problem? Critics say the government is engaging in censorship by telling the media what it should and should not write about. It sets a terrible precedent, they argue, for the government to set itself up as a national-security censor. The next time, they say, the government will try to prevent the publication of information that is far less dangerous than contagious bird flu.

Press-freedom watchdogs have a point: the government often trots out national security to try to intimidate the press into not doing its job. A few years back, the New York Times was about to expose the NSA spying program, in which the government was intercepting emails and phone calls without getting court orders. President George W. Bush called the paper’s top brass down to the White House and warned them that exposing the program would compromise national security. The Times went ahead and published — and we are all still here.

The skeptics raise another important concern: the long tradition of scientific openness. Research science works by having experiments reported publicly, so other scientists can test the findings — and build on them with their own research. This tradition breaks down when the government puts a shroud of secrecy on some research.

The editor of Science has suggested that his journal might agree to withhold the information the advisory board is worried about — provided that the government creates a system that would allow legitimate scientists to access the full results.

That sounds like the right answer. We should be wary of government attempts to stop the media from publishing information. But in extreme cases, it may be necessary — and weaponizable highly contagious bird flu could be just such a case.

What factors should we be looking for in considering whether the government should try to stop publication? First, the threat of harm should be real and it should be truly extraordinary. That is a test the contagious strain of H5N1 seems to meet. Second, it should be clear that the government has no ulterior motives — that it is acting to protect the nation, not to advance a political agenda.

That can be a tough thing to evaluate — governments that use national-security arguments for political goals are quick to deny that they are doing so. The best check on this sort of politicization is making sure that anyone who feels pressure from the government not to publish or speak is able to challenge the policy in court. Judges are in the best position to balance risks of serious harm against the infringement on speech — and to determine whether the government is crossing any First Amendment lines.

Those who oppose the Scientific Advisory Board’s decision are right that we must be wary whenever the government tries to suppress speech. As Supreme Court Justice Potter Stewart said, censorship is “the hallmark of an authoritarian regime.” But the board’s defenders are right that ultimately the government has a duty to protect the public from the most serious threats. They can cite Supreme Court Justice Robert Jackson, who noted that the Constitution is not a suicide pact (TIME, 2011).

Title: Debate Persists On Deadly Flu Made Airborne
Date: December 27, 2011
Source: NDTV

Abstract: The young scientist, normally calm and measured, seemed edgy when he stopped by his boss's office.

"You are not going to believe this one," he told Ron Fouchier, a virologist at the Erasmus Medical Center in Rotterdam. "I think we have an airborne H5N1 virus."

The news, delivered one afternoon last July, was chilling. It meant that Dr. Fouchier's research group had taken one of the most dangerous flu viruses ever known and made it even more dangerous - by tweaking it genetically to make it more contagious.

What shocked the researchers was how easy it had been, Dr. Fouchier said. Just a few mutations was all it took to make the virus go airborne.

The discovery has led advisers to the United States government, which paid for the research, to urge that the details be kept secret and not published in scientific journals to prevent the work from being replicated by terrorists, hostile governments or rogue scientists.

Journal editors are taking the recommendation seriously, even though they normally resist any form of censorship. Scientists, too, usually insist on their freedom to share information, but fears of terrorism have led some to say this information is too dangerous to share.

Some biosecurity experts have even said that no scientist should have been allowed to create such a deadly germ in the first place, and they warn that not just the blueprints but the virus itself could somehow leak or be stolen from the laboratory.

Dr. Fouchier is cooperating with the request to withhold some data, but reluctantly. He thinks other scientists need the information.

The naturally occurring A(H5N1) virus is quite lethal without genetic tinkering. It already causes an exceptionally high death rate in humans, more than 50 percent. But the virus, a type of bird flu, does not often infect people, and when it does, they almost never transmit it to one another.

If, however, that were to change and bird flu were to develop the ability to spread from person to person, scientists fear that it could cause the deadliest flu pandemic in history.

The experiment in Rotterdam transformed the virus into the supergerm of virologists' nightmares, enabling it to spread from one animal to another through the air. The work was done in ferrets, which catch flu the same way people do and are considered the best model for studying it.

"This research should not have been done," said Richard H. Ebright, a chemistry professor and bioweapons expert at Rutgers University who has long opposed such research. He warned that germs that could be used as bioweapons had already been unintentionally released hundreds of times from labs in the United States and predicted that the same thing would happen with the new virus.

"It will inevitably escape, and within a decade," he said.

But Dr. Fouchier and many public health experts argue that the experiment had to be done.

If scientists can make the virus more transmissible in the lab, then it can also happen in nature, Dr. Fouchier said.

Knowing that the risk is real should drive countries where the virus is circulating in birds to take urgent steps to eradicate it, he said. And knowing which mutations lead to transmissibility should help scientists all over the world who monitor bird flu to recognize if and when a circulating strain starts to develop pandemic potential.

"There are highly respected virologists who thought until a few years ago that H5N1 could never become airborne between mammals," Dr. Fouchier said. "I wasn't convinced. To prove these guys wrong, we needed to make a virus that is transmissible."

Other virologists differ. Dr. W. Ian Lipkin of Columbia University questioned the need for the research and rejected Dr. Fouchier's contention that making a virus transmissible in the laboratory proves that it can or will happen in nature. But Richard J. Webby, a virologist at the St. Jude Children's Research Hospital in Memphis, said Dr. Fouchier's research was useful, with the potential to answer major questions about flu viruses, like what makes them transmissible and how some that appear to infect only animals can suddenly invade humans as well.

"I would certainly love to be able to see that information," Dr. Webby said, explaining that he has a freezer full of bird flu viruses from all over the world. "If I detect a virus in our activities that has some of these changes, it could change the direction of what we do."

Some scientists dismiss fears of bioterrorism via influenza, because flu viruses would not make practical weapons: they cannot be targeted, and they would also infect whoever deployed them.

Dr. Fouchier said it would be easier to weaponize other germs. Which ones? He would not answer.

"That should tell you something," he said. "I won't tell you what I as a virologist would use, but I would publish this work."

However, some experts argue that appeals to logic are useless.

"You can't know who might try to re-create H5N1," said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

The A(H5N1) bird flu was first recognized in Hong Kong in 1997, when chickens in poultry markets began dying and 18 people fell ill, 6 of them fatally. Hoping to stamp out the virus, the government in Hong Kong destroyed the country's entire poultry industry - killing more than a million birds - in just a few days. Buddhist monks and nuns in Hong Kong prayed for the souls of the slaughtered chickens, and world health officials praised Hong Kong for averting a potential pandemic.

But the virus persisted in other parts of Asia, and reached Europe and Africa; that worries scientists, because most bird flus emerge briefly and then vanish. Millions of infected birds have died, and many millions more have been slaughtered. Since 1997, about 600 humans have been infected, and more than half died.

Dr. Donald A. Henderson, a leader in the eradication of smallpox and now a biosecurity expert at the University of Pittsburgh, noted that even the notorious flu pandemic of 1918 killed only 2 percent of patients.

"This is running at 50 percent or more," Dr. Henderson said. "This would be the ultimate organism as far as destruction of population is concerned."

Dr. Fouchier was working on AIDS when the first bird flu outbreak occurred. He immediately became fascinated by the new disease and gave up AIDS to study it. He has worked on bird flu for more than a decade.

The medical center in Rotterdam built a special 1,000-square-foot virus lab for this work, a locked-down place where people work in spacesuits in sealed chambers with filtered air and multiple precautions to keep germs in and intruders out and to protect the scientists from infection. Dr. Fouchier said that even more security measures had been added recently because of the publicity about his work.

The Dutch government and the United States Centers for Disease Control and Prevention approved the laboratory, and the National Institutes of Health gave the Erasmus center a seven-year contract for flu research.

Because a government advisory panel has recommended that the full recipe for mutating the bird flu virus not be published, Dr. Fouchier declined to explain much about how it was done.

But he previously described the work at a public meeting, and various publications have reported that the experiment involved creating mutations in the virus and then squirting it into the respiratory tracts of ferrets. When the ferrets got sick, the researchers would collect their nasal secretions and expose other ferrets to the virus. After repetitions of this process, a strain of virus emerged from sick ferrets last summer that could infect animals in nearby cages without being squirted into them - just by traveling through the air.

The published reports say five mutations were all it took to transform the virus. Dr. Fouchier declined to confirm or deny that, and would say only that it took "a handful" of mutations.

Looking back on that day in July with Sander Herfst, the member of his team who told him the virus had gone airborne, Dr. Fouchier said, "We both needed a beer to recover from the shock."

Then they planned their next step, repeating the experiment to make sure the results were reliable. There was one major obstacle: they had run out of ferrets. They ordered a new shipment from Scandinavia. So they had to wait several weeks to find out whether their discovery was real. Dr. Herfst took a vacation, timed to end the day the ferrets arrived.

They ran the tests again. Once more, A(H5N1) went airborne (NDTV, 2011).

Title: We Need To Fix The Holey Biosafety Net
Date:
January 13, 2012
Source:
NewScientist


Abstract:
Physics lost its innocence on 16 July 1945, when researchers involved in the Manhattan Project witnessed the first detonation of an atomic bomb. Years later, Robert Oppenheimer recalled that he was haunted by a verse from the Hindu scripture, the Bhagavad Gita: "I am become death, the destroyer of worlds."

Ron Fouchier and Yoshihiro Kawaoka haven't yet revealed their thoughts on learning that they had created flu viruses that could potentially kill tens of millions of people (see "One mistake away from a worldwide flu pandemic"). But with opinion divided on the wisdom of running the experiments, biology may have crossed a similar line.

The circumstances are very different, of course. Oppenheimer and his colleagues were trying to defeat tyranny. Fouchier and Kawaoka were motivated by a desire for knowledge that they argue will make the world safer.

The trouble is that in the wrong hands, or if handled carelessly, these viruses may be just as dangerous as a nuclear bomb. Fouchier and Kawaoka believe that understanding how the deadly H5N1 virus can become easily transmissible between people is crucial knowledge. Others argue that the experiments don't mimic what might happen in nature, and that the risks outweigh any benefits.

But what is done is done. The question now is, what can be learned from this episode?

First and foremost we must ask how it came to this. The research was first reported at a conference last September, yet the US National Science Advisory Board for Biosecurity (NSABB) was not asked for its opinion until later, as two papers describing the work neared publication. The board has now recommended that key details should be withheld from these papers - though whether that will be enough to neutralise any danger is debatable.

While no one doubts the researchers' good intentions, one has to ask how the work progressed so far without a wider debate. In 2007, NSABB drew up a framework for proactively weighing up the risks and benefits of experiments that might provide a recipe for bioterror. It was supposed to serve as a springboard for action, but has simply gathered dust. Before the framework, New Scientist flagged up a grant to Kawaoka which eventually paid for his flu experiments in an article on the pros and cons of such research (14 October 2006, p 20).

The US National Institutes of Health, which funded Fouchier's and Kawaoka's work, says that the US government will now develop a policy to "augment existing approaches" to evaluating such research - though it has not said what this means in practice.

Better late than never. But it is important not to overreact. As we warned more than five years ago, some security specialists see bioterrorists under every bed. If their views were to dominate, important research would become tangled in red tape.

The reality is that a vanishingly small number of projects present such dilemmas. But those that do need to be flagged up earlier in the game and subjected to scrutiny. The scientists involved must also accept that others can legitimately question whether everything that can be done should be done, lest they follow in Oppenheimer's deadly footsteps (NewScientist, 2012).

Title: In Dramatic Move, Flu Researchers Announce Moratorium On Some H5N1 Flu Research, Call For Global Summit
Date: January 20, 2012
Source: Science Mag

Abstract: Stung by a growing global controversy over the potential dangers of experiments involving the H5N1 avian flu virus—and worried about heavy-handed government regulation—the world's leading H5N1 researchers have agreed to a 60-day moratorium on a controversial category of studies "to allow time for international discussion."

"We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks," a group of 39 researchers write in a statement published today by Science and Nature. "To provide time for these discussions, we have agreed on a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals."

"It's a pity that it has to come to this," says Ron Fouchier, of Erasmus Medical Center in Rotterdam, the Netherlands, one of the scientists who took the initiative for the announcement. (Fouchier's H5N1 paper, under review by Science, was one of two that triggered the international debate.) "I would have preferred if this hadn't caused so much controversy, but it has happened and we can't change that. So I think it's the right step to make."

The group calls for "an international forum in which the scientific community comes together to discuss and debate these issues. We realize organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work." That meeting will be hosted by the World Health Organization (WHO) in Geneva in late February, sources tell ScienceInsider.

Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, which funded the studies, strongly supports the moratorium and discussed it at length with Fouchier. "I thought it would be a good idea for the investigators themselves to call for a time-out rather than seeming like we're rushed," says Fauci. "He said if I'm going to do it, let me take the pulse of the others in the field. I really admire that and the fact that he agreed to do it. I felt strongly this was the way to go."

Fauci says he hopes the moratorium will lead to "a more transparent and intelligent discussion" by regulators, scientists, and the public about the issues raised by these experiments. "I have concerns that people understandably concerned about security may put restrictions on important research that might go a little bit too far," he says. "We have to be extremely sensitive to safety and security, and everyone is in agreement on that, but what I would not want to see is an overreaction."

One vocal critic of the flu studies, however, is not impressed, calling the moratorium "pure PR." The letter "includes flatly false statements" about the safety of influenza research labs, Richard Ebright, a biologist at Rutgers University in Piscataway, New Jersey, and the Howard Hughes Medical Institute, wrote in an e-mail. And "the letter rejects, out of hand, the need for enhanced biosafety, biosecurity, and dual-use oversight, and, instead, maintains that all that is needed is an opportunity for researchers 'to assure the public' and 'to clearly explain the benefits of this important research and the measures taken to minimize its possible risk.'" The letter is "strictly symbolic," he writes. "An empty gesture."

"I welcome this development," wrote another critic, John Steinbruner of the University of Maryland, College Park. "But I question the capacity of 'governments' to do anything meaningful within the 60 day period of the announced moratorium. What happens if they do not?" And Steinbruner says he would feel more reassured about the safety of H5N1 research if it took place in more secure laboratories.

The call for the moratorium and summit follows months of rising tension over two studies that describe how researchers made the deadly H5N1 avian influenza more transmissible between mammals—possibly providing a blueprint on how to set off a flu pandemic. In late December 2011, the U.S. National Science Advisory Board for Biosecurity (NSABB) asked flu researchers to strike key details from the papers, which are in press at Science and Nature. The researchers and the journals agreed, provided that the U.S. government comes up with a mechanism to share those details with bona fide researchers and public health experts. But the deal has sparked extensive criticism—with some scientists saying the redactions went too far, and others arguing the research should not have been conducted in the first place.

Meanwhile, the episode prompted the U.S. government to rapidly restart a long, moribund process aimed at tightening oversight of so-called "dual use" research—and WHO to complain that the deal could imperil a carefully negotiated global agreement to share flu viruses and research results. Earlier this month, a New York Times editorial, headlined, "An Engineered Doomsday," even called for the scientists to destroy the H5N1 variants they had created in the name of safety. In Washington, science policy experts warned that, unless the scientific community could reassure the public and lawmakers that it could adequately regulate itself, the controversy could result in onerous new regulations. "The debate is so controversial that we can't rule that out," Fouchier says. "We'd rather have everybody take a breather to reflect carefully on how to handle this."

Against that backdrop, leading scientists—including NSABB Chair Paul Keim, a microbiologist at Northern Arizona University, Flagstaff—began promoting the idea of a moratorium. It is modeled in part after a landmark moratorium agreed to by recombinant DNA researchers in 1975, who were also facing public doubts about the safety of their new field of research and potential government regulation. That moratorium led to a meeting in Asilomar, California, at which scientists drew up safety guidelines for genetic engineering.

Signers of today's moratorium agreement include the leaders of virtually every major lab in the world conducting H5N1 research.

"The continuous threat of an influenza pandemic represents one of the biggest challenges in public health," the statement begins. "A major obstacle in preventing influenza pandemics is that little is known regarding what makes an influenza virus transmissible in humans. As a consequence, the potential pandemic risk associated with the many different influenza viruses of animals cannot be assessed with any certainty."

In addition to halting H5N1 transmissibility research, "no experiments with live H5N1 or H5 HA reassortant viruses already shown to be transmissible in ferrets will be conducted during this time. We will continue to assess the transmissibility of H5N1 influenza viruses that emerge in nature and pose a continuing threat to human health."

The statement also seeks to reassure the public about safety. Labs currently conducting H5N1 research use "the highest international standards of biosafety and biosecurity practices that effectively prevent the release of transmissible viruses from the laboratory," the authors note. Still, "a perceived fear that the ferret-transmissible H5 HA viruses may escape from the laboratories has generated intense public debate in the media on the benefits and potential harm of this type of research. We would like to assure the public that these experiments have been conducted with appropriate regulatory oversight in secure containment facilities by highly trained and responsible personnel to minimize any risk of accidental release. Whether the ferret-adapted influenza viruses have the ability to transmit from human to human cannot be tested."

According to several sources, WHO is planning a meeting in late February to discuss the issues raised by the research. One of the organization's main worries is that limiting access to the research results and the virus would flout the new pandemic influenza preparedness (PIP) framework, agreed to earlier this year after 4 years of often-acrimonious debate. That agreement stipulates that countries that provide virus samples should also receive the benefits of research with the virus. The main benefit of the research, says WHO in a statement sent to ScienceInsider, is the knowledge that the virus is potentially capable of spreading between mammals and therefore "must continue to be regarded as a high priority risk for pandemic flu. "Beyond that, however, knowing which mutations make transmission possible will be an important tool for global surveillance efforts, it says. Limiting access to that data could hamper global efforts to contain potential pandemic strains.

WHO isn't the only organization that will be hosting discussions of the issue. The American Society for Microbiology is hosting a discussion of the NSABB controversy at a major biodefense meeting in Washington, D.C., on 29 February, and AAAS, the publisher of Science and ScienceInsider, has added panels on the topic to its annual meeting, to be held in Vancouver, Canada, on 16-20 February (Science Mag, 2012)

Title: Pause On Avian Flu Transmission Research
Date: January 20, 2012
Source: Science Mag

Abstract: The continuous threat of an influenza pandemic represents one of the biggest challenges in public health. Influenza pandemics are known to be caused by viruses that evolve from animal reservoirs, such as in birds and pigs, and can acquire genetic changes that increase their ability to transmit in humans. Pandemic preparedness plans have been implemented worldwide to mitigate the impact of influenza pandemics. A major obstacle in preventing influenza pandemics is that little is known regarding what makes an influenza virus transmissible in humans. As a consequence, the potential pandemic risk associated with the many different influenza viruses of animals cannot be assessed with any certainty. Recent research breakthroughs identified specific determinants of transmission of H5N1 influenza viruses in ferrets. Responsible research on influenza virus transmission using different animal models is conducted by multiple laboratories in the world using the highest international standards of biosafety and biosecurity practices that effectively prevent the release of transmissible viruses from the laboratory. These standards are regulated and monitored closely by the relevant authorities.

This statement is being made by the principal investigators of these laboratories. In two independent studies conducted in two leading influenza laboratories at the University of Wisconsin–Madison and Erasmus MC in Rotterdam, the Netherlands, investigators have proved that viruses possessing a haemagglutinin (HA) protein from highly pathogenic avian H5N1 influenza
viruses can become transmissible in ferrets. This is critical information that advances our understanding of influenza transmission. However, more research is needed to determine how influenza viruses in nature become human pandemic threats, so that they can be contained before they acquire the ability to transmit from human to human, or so that appropriate countermeasures can be deployed if adaptation to humans occurs.

Despite the positive public health benefits these studies sought to provide, a perceived fear that the ferrettransmissible
H5 HA viruses may escape from the laboratories has generated intense public debate in the media on the benefits and potential harm of this type of research. We would like to assure the public that these experiments have been conducted with appropriate regulatory oversight in secure containment facilities by highly trained and responsible personnel to minimize any risk of accidental release. Whether the ferret-adapted influenza viruses have the ability to transmit from human to human cannot be tested. We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks. We propose to do so in an international forum in which the
scientific community comes together to discuss and debate these issues. We realize that organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work. To provide time for these discussions, we have agreed on a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals.

In addition, no experiments with live H5N1 or H5 HA reassortant viruses already shown to be transmissible in ferrets will be conducted during this time. We will continue to assess the transmissibility of H5N1 influenza viruses that emerge in nature and pose a continuing threat to human health (Science Mag, 2012).

Title: Flu Researcher Ron Fouchier: 'It's A Pity That It Has To Come To This'
Date: January 20, 2012
Source: Science Mag

Abstract: In a statement posted today on the Web sites of Nature and Science, a group of 39 influenza researchers announced a 2-month moratorium on studies that make the avian influenza strain H5N1 more transmissible between mammals. The moratorium is intended to allow time for an international debate about this type of research, which some people say has the potential to help bioterrorists.

ScienceInsider talked to Ron Fouchier of Erasmus MC in Rotterdam, the Netherlands, who carried out one of the two studies that triggered the international debate. (His paper is under review at Science.) Fouchier's answers have been translated from Dutch and edited for clarity and brevity.

Q: Who took the initiative for this announcement?

R.F.: The initiative came from Adolfo Sastre-García [an influenza researcher at Mount Sinai Medical Center in New York City who has a grant from the National Institute of Allergy and Infectious Diseases (NIAID) that funded Fouchier's study], Yoshihiro Kawaoka [whose H5N1 study, in press at Nature, has also been reviewed by the U.S. National Science Advisory Board for Biosecurity (NSABB)], and myself. We discussed it with a group of about 10 scientists who are doing similar studies themselves; then we asked another 30 or so influenza researchers who are not working on these studies but who could do them, if they wanted to sign. They all agreed wholeheartedly. So it's not a Fouchier show. It's an initiative that is supported very broadly.

Q: Why did you take this step now?

R.F.: We were advised by various organizations, and of course we've followed the press coverage and the political debates. We had the impression, based partly on advice from third parties, that it would be sensible to announce a moratorium.

Q: Which third parties?

R.F.: The organizations that fund our research, but also governments that we are talking to. So much is happening at the moment that it makes sense to take a break, to give the infectious diseases field time to think this over and talk about how to handle this kind of research in the future. This research offers opportunities and challenges, and governments and organizations need time to react.

Q: Are you doing this because if you don't, governments might move to halt the research?

R.F.: The debate is so controversial that we can't rule that out. We'd rather have everybody take a breather to reflect carefully on how to handle this.

Q: But have you received clear signals that there might be a ban of some sort?

R.F.: We don't have clear signals that something is about to happen, but you see the signals in the press, from experts and advisers, and those signals reach governments as well. We see articles from Michael Osterholm [director of the Center for Infectious Disease Research and Policy at the University of Minnesota, and an influenza expert], and from people like Laurie Garrett, the Pulitzer Prize winning author [and a Senior Fellow for Global Health at the Council on Foreign Relations]. And then there are the biosecurity experts at the University of Pittsburgh, like Thomas Inglesby. ... And [smallpox eradication leader] D. A. Henderson has been very vocal . All of these people can have quite an impact on the White House and elsewhere.

Q: How do you feel about the moratorium yourself?

R.F.: It's a pity that it has to come to this. I would have preferred if this hadn't caused so much controversy, but it has happened and we can't change that. So I think it's the right step to make. It's comparable to what happened in 1975 at the Asilomar conference. But I think that was driven more by the scientists themselves; this time it's mostly the public controversies that drive it.

Q: Do you have ideas about how the debate about these studies should be organized and who should participate?

R.F.: I think there has to be a whole series of debates. A couple are on the rails already. As we say in our statement, a meeting will be organized in the next couple of weeks, which I hope will include participation of the World Health Organization (WHO) and the U.S. government. The [American Society for Microbiology] has organized a plenary session at its biodefense meeting next month. The New York Academy of Sciences has a meeting as well. People need to talk, and infectious diseases specialists need to take the microphone and explain why this research is important and how you can do it safely.

Q: Has the scale of the controversy surprised you? Had you expected this when you first discussed the study at a meeting in Malta in September?

R.F.: When we presented this, of course we expected that there would be some commotion, and that we would have to explain to the public and the press why we're doing this and how you can do it safely.

I think we have done that very well in the Netherlands. We were very proactive; before we submitted the paper for publication we informed all the relevant authorities, so they knew what was happening and had the time to prepare, and when the story started making the rounds in the U.S. media, we spent 3 days talking to newspapers, TV, and radio. And that nipped the debate in the bud. In the U.S., this hasn't happened. And the people who are the most vocal in the press are the biosecurity experts. It's a pity that so few people from the flu field have jumped in front of the cameras, especially in the U.S.

Q: Did the NSABB recommendations take you by surprise?

R.F.: Absolutely. This was something that was unprecedented, and something I wasn't counting on at all.

NSABB has said that the risks outweigh the benefits, and now many people are saying: In that case, you shouldn't do this research at all. That's a very logical response. But the infectious disease community doesn't agree with NSABB on this. What NSABB should explain better is what the risks are exactly. How much bioterrorism have we seen in the past? What are the chances that bioterrorists will recreate these viruses? And is it really true that publication of this research would give bioterrorists or rogue nations an advantage? That's what I would like to hear from the NSABB.

Q: You think it doesn't give them an advantage?

R.F.: No. Because bioterrorists can't make this virus, it's too complex, you need a lot of expertise. And rogue nations that do have the capacity to do this don't need our information. So I don't think they will benefit from this information at all. Meanwhile, NSABB gives very little credit to the public health benefits, while the entire influenza community is crying just how important that is. For them the balance between risk and benefit is very different than for NSABB.

Q: But NSABB has several infectious disease researchers among its members, including Osterholm, who's an influenza expert himself. And they hired Robert Webster, a flu researcher at St. Jude Children's Research Hospital in Memphis, as a special adviser.

R.F.: The question is whether that was enough, or whether they should have asked more influenza experts. If they had asked somebody like Peter Palese of Mount Sinai School of Medicine, you would have had a very different answer. If you read his piece in Nature—I think he was totally right.

Osterholm, in his article [published yesterday with Henderson] in Science, has a very fatalistic attitude. He says countries in Asia, Africa, and the Middle East are unable to do surveillance, so they don't need the data from our paper. That's too fatalistic. It would be better to say: How can we help those countries set up a decent surveillance system? Osterholm also says that the data make no difference for vaccine development. That's really based on nothing. So if that is the influenza expert within NSABB, I'd like to see someone with a more positive attitude.

Q: How will the moratorium affect research at your own lab?

R.F.: We were of course working to find out exactly which mutations cause the virus to become transmissible by aerosol. That is going to stop now; we were almost done with that, but not quite. We were working to find out which biological properties of the virus are associated with the mutations that we have found. The biological properties of the virus are really more important than the mutations themselves.

Q: What biological properties are you referring to?

R.F.: In a paper in Current Opinion in Virology, we said we thought there were a number of things that might make an avian influenza virus transmissible between mammals. At the time, that was purely hypothetical. We said the virus probably has to do better in the upper respiratory tract than deep inside the lungs; it must bind to certain mammalian receptors; it has to reproduce in large amounts, to increase chances of transmission; it has to be stable in small droplets, and so on.

Now that we have these mutations, we can look at each of these steps to see if they occur. And you will see that for each step, there are multiple options, more possible mutations than just the ones we have found so far. So that's very important.

Something else that has to happen is evaluating existing vaccines and antiviral drugs. Until now, we only have looked in vitro whether these virus's characteristics match existing vaccine strains, and whether the virus is sensitive to antiviral drugs. We haven't tried it in our animal model yet.

Q: You also want to repeat the experiments with more H5N1 strains?

R.F.: Yes. We did this with one genetic lineage of the H5N1 virus. The question is whether all lineages can become aerosol-transmissible. If they can't, if it's just this lineage, perhaps you can focus on the region where it came from and try to stop H5N1 outbreaks there to prevent a pandemic. If it can happen everywhere, you've got to work everywhere.

Q: Would you also like to do similar studies in other avian influenza strains, such as H7N7?

R.F.: That is certainly something we'd like to do in the long run. But that has a much lower priority because we're not seeing H7N7 outbreaks at the moment, and we're definitely not going to do that anytime soon; I don't think that would be wise.

Q: Have you had requests from other labs to share the virus you have created?

R.F.: Not explicitly. Everybody understands that this is not the right time to ask.

Q: But if they did ask, what would you do?

R.F.: I have an agreement with our funder, the NIAID, that if such requests were made, I will discuss it with them. So I can't decide that on my own.

Q: Andrew Pekosz recently told Science that a moratorium would be especially harmful for the young scientists who do the actual lab work. Do you see that as a problem?

R.F.: I think that that is a small problem compared to the other issues. I have a postdoc here, Sander Herfst, who has worked on this extremely hard for 4 years and for whom a terrific breakthrough in his career is on hold. But those are individual cases. I think the repercussions of the NSABB recommendations for the life sciences are much more important. If we get very strict new guidelines for prescreening proposals, I think that could hobble the life sciences for years.

Q: In a policy forum you co-authored and which was published yesterday on Science's Web site, you suggest that you cannot promise to always keep the key details from your paper secret. Under what circumstances would you decide to reveal them?

R.F.: Well, Science and we have said that we're going to try to adhere to NSABB's recommendations. The U.S. government is now searching for a mechanism to share the key details with people who have a legitimate need to see them, but this is far from easy; there are all kinds of legal issues. So what that mechanism will look like and whom that information can be shared with is very unclear.

Meanwhile, WHO has said: This research is super-important, but it's just as important that the data are shared, or it could mean the end of the Pandemic Influenza Preparedness Framework. And rightly so, because that framework is very important for surveillance systems. Suppose it would collapse if for whatever reason the manuscript couldn't be shared with certain people. Then we'll have to talk to the U.S. government and WHO. That could happen. Again, you will have to weigh benefits and risks.

Also, as researchers, we work very closely with people in Indonesia. It would be very unwise for us not to share our results with our close collaborators.

Q: So if those researchers weren't approved to make use of the sharing mechanism ...

R.F.: I don't know who will be at the controls of that mechanism, and what the arguments would be for denying access to certain people. But if the result is that I can't share details with my collaborators, then I have a problem. That kind of situation can arise. So we're giving the American government and the NSABB the chance to set up a mechanism, and we are waiting what they come up with. But we cannot say now that we will never share that information.

Q: When do you think you will know more about that mechanism and the publication of your paper?

R.F.: The previous deadline was the end of January, but from what I have heard, the U.S. government has asked for a 4-week extension. So I think it will be late February.

Q: Are you in touch with Yoshihiro Kawaoka?

R.F.: On a daily basis.

Q: You have been all over the press while he has remained completely silent. Wouldn't you have preferred to make the case for these studies together?

R.F.: We both made a conscious choice to do what we did. I feel I have a responsibility to defend my point of view and to answer those media calls. And of course I made that decision when I decided to go to Malta. He hasn't talked about his work at a meeting, so what he has done is still under wraps in that paper at Nature. And I can understand his decision; he has two labs to run, one in Japan and one in the U.S. Frankly, the last 3 months I have done nothing but politics, press, and things like that. I don't have time for my science anymore (Sience Mag, 2012).

Title: Bioterror Fears Halt Research On Mutant Bird Flu
Date: January 20, 2012
Source:
BBC

Abstract: Scientists who created a potentially more deadly bird flu strain have temporarily stopped their research amid fears it could be used by terrorists.

In a letter published in Science and Nature, the teams call for an "international forum" to debate the risks and value of the studies.

US authorities last month asked the authors of the research to redact key details in forthcoming publications.

A government advisory panel suggested the data could be used by terrorists.

Biosecurity experts fear an altered, more contagious form of the virus could spark a pandemic deadlier than the 1918-19 Spanish flu outbreak that killed up to 40 million people.

'Right Step'

The National Science Advisory Board for Biosecurity (NSABB) recommended key details be omitted from publication of the research, which sparked international furore.

"I would have preferred if this hadn't caused so much controversy, but it has happened and we can't change that," Ron Fouchier, a researcher from Erasmus Medical Center in Rotterdam, told Science Insider.

"So I think it's the right step to make."

While the H5N1 strain of bird flu is extremely deadly when caught by humans, its impact has so far been limited because it is not easily transmissible between humans.

But the latest joint research, by Erasmus University in the Netherlands and the University of Wisconsin-Madison in the US, altered the strain and found it was much more easily passed between ferrets

Two scientific journals now want to publish the research - albeit in redacted form - and are trying to work out with the US government how to make the data accessible to "responsible scientists".

The World Health Organization said in a December statement that limiting access to the research would harm an agreement between its members.

The NSABB is made up of scientists and public health experts, 23 from outside the government, and 18 from within.

'Flatly False'

It cannot stop publication but makes recommendations to researchers.

The scientists' letter published on Friday argues that knowledge of more infectious strains before they mutate in nature is valuable for public health.

"More research is needed to determine how influenza viruses in nature become human pandemic threats," the statement says, "so that they can be contained before they acquire the ability to transmit from human to human, or so that appropriate countermeasures can be deployed if adaptation to humans occurs."

But some said the 60-day pause on research was not enough.

One critic of the studies, Richard Ebright, a biologist at Rutgers University, told Science Insider that the letter "includes flatly false statements" making assurances about the safety of H1N1 research labs.

Reports say that a meeting debating the research and steps forward could come during a World Health Organization meeting in February (BBC, 2012).

Title: Bio-Terror Fear Halts Bird Flu Research
Date: January 21, 2012
Source: Fox News

Abstract: Scientists who created easier-to-spread versions of the deadly bird flu said Friday they're temporarily halting more research, as international specialists debate what should happen next.

Researchers from leading flu laboratories around the world signed onto the voluntary moratorium, published Friday in the journals Science and Nature.

What the scientists called a "pause" comes amid fierce controversy over how to handle research that's high-risk but potentially could bring a big payoff. Two labs — at Erasmus University in the Netherlands and the University of Wisconsin-Madison — created the new viruses while studying how bird flu might mutate to become a bigger threat to people.

The U.S. government funded the work but last month urged the teams not to publicly reveal the exact formula so that would-be bioterrorists couldn't copy it. Critics also worried a lab accident might allow the strains to escape. The researchers reluctantly agreed not to publish all the details as long as the government set up a system to provide them to legitimate scientists who really need to know. The National Institutes of Health is creating such a system.

"We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks," lead researchers Ron Fouchier of Erasmus and Yoshihiro Kawaoka of Wisconsin wrote Friday in the letter. They were joined by nearly three dozen other flu researchers.

They called for a public international meeting to debate how to learn from the work, safely. And they agreed to hold off on additional research with the existing lab-bred strains or that leads to any new ones for 60 days.

A U.S. official praised the development.

The moratorium "is a really good idea, because a lot of very important issues are at hand," said Dr. Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, who expects most flu researchers doing such work to sign on. "There aren't a lot of people who are doing that, I can assure you."

The U.S. also wants international input; researchers are talking with the World Health Organization.

Today, the so-called H5N1 bird flu only occasionally infects people, mostly those who have close contact with sick poultry. But when it does, it's highly lethal. The lab-bred H5N1 strains were a surprise because they showed it was easier than previously thought for the virus to mutate in a way that lets it spread easily between at least some mammals — in this case, ferrets (Fox News, 2012).

Title: Bird Flu Mutation Study Stopped In Fear Of Deadly Global Outbreak
Date: January 21, 2012
Source: Russia Today

Abstract: Under pressure to put their research on hold due to fear of a biological disaster, an international team of scientists have voluntarily suspended their study on an advanced, incredibly deadly mutation of the H5N1 bird flu.

In an effort to better understand the deadly bird flu virus, Ron Fouchier of Erasmus Medical College in the Netherlands, Adolfo Garcia-Sastre of Mount Sinai School of Medicine in New York and Yoshihiro Kawaoka of the University of Wisconsin, Madison have been slaving over their study of the avian influenza. In conducting their own research, the team of scientists was able to mutate the original H5N1 virus into a much more lethal form to see how the outbreak could increase in intensity if not controlled outside of the lab. As word came around late last year that their research had returned a variation able to induce an international outbreak, however, the scientific community urged them to abandon their study in fear that the mutated strain would escape the lab and cause a deadly, worldwide outbreak.

With the fear failing to subside weeks later, the team of scientists has temporarily halted their research.

In its natural form, the bird flu virus has led to nearly 600 known cases and 340 deaths since it was discovered in 2003. That year there were only four outbreaks, all in East Asia, although in the years since an outbreak has claimed lives as far west as Egypt. The scientists were studying what damage a mutated strain of the virus could bring, but the US National Science Advisory Board for Biosecurity cautioned them to refrain from publishing the results of their finding, fearful that it would influence budding bioterrorists to use the study to create their own strain and launch an epidemic.

Despite the Board’s urging, others in the science community were skeptical. "In the end, is the likelihood of misuse outweighed by the danger of beginning a Big Brother society?" Professor Wendy Barclay of Imperial College London asked the Daily Mail last month.

The researchers say in a letter published in the journals Nature and Science on Friday that they will take a two-month break from their efforts. Since news of their study caught wind, the US government, the World Health Organization and other international bodies have been evaluating a way to go about publishing the findings in periodicals eventually, taking into account their research but avoiding the publishing of a how-go guide for biological warfare.

“We realize that organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work,” the scientists write.

“We hope that by having a calm and reasoned discussion of the facts, scientists and biosecurity experts can reach a better understanding and find ways to enable the research to go forward while minimizing risks,” adds Kawaoka (Russia Today, 2012).

Title: Lab-Engineered H5N1 Not Fatal, Lead Scientist Says
Date: January 26, 2012
Source:
Bio Prep Watch

Abstract: According to the lead scientist of the lab-engineered airborne strain of avian flu in Wisconsin, the strain is not lethal and can be defeated with existing medicines.

Yoshihiro Kawaoka, a professor of virology at the University of Wisconsin, said that while the mutated virus was contagious among ferrets in the lab, it did not kill any of them. In a commentary published on Wednesday in the journal Nature, Kawaoka said that more research is needed urgently on transmissible bird-flu strains, Bloomberg reports.

“(There is an urgent need) to expand development, production and distribution (of bird-flu vaccines) and to stockpile antiviral compounds,” Kawaoka said, according to Bloomberg. “(Censoring the findings) will make it harder for legitimate scientists to get this information while failing to provide a barrier to those who would do harm.”

Kawaoka was among the scientists who ceased their experiments for 60 days in response to the widespread media fear that the virus could escape from labs and infect humans. The research team in Wisconsin agreed to not publish certain details of their research after being requested to do so by a U.S. biosecurity panel.

The U.S. National Science Advisory Board for Biosecurity recommended that the studies done by Kawaoka’s group and a Dutch team led by Ron Fouchier of the Erasmus Medical Center not be published in full. The panel determined the risks of publishing the complete research would outweigh the benefits (Bio Prep Watch, 2012).

Title: Lab-Engineered H5N1 Not Fatal, Lead Scientist Says
Date: January 26, 2012
Source:
Bio Prep Watch

Abstract: According to the lead scientist of the lab-engineered airborne strain of avian flu in Wisconsin, the strain is not lethal and can be defeated with existing medicines.

Yoshihiro Kawaoka, a professor of virology at the University of Wisconsin, said that while the mutated virus was contagious among ferrets in the lab, it did not kill any of them. In a commentary published on Wednesday in the journal Nature, Kawaoka said that more research is needed urgently on transmissible bird-flu strains, Bloomberg reports.

“(There is an urgent need) to expand development, production and distribution (of bird-flu vaccines) and to stockpile antiviral compounds,” Kawaoka said, according to Bloomberg. “(Censoring the findings) will make it harder for legitimate scientists to get this information while failing to provide a barrier to those who would do harm.”

Kawaoka was among the scientists who ceased their experiments for 60 days in response to the widespread media fear that the virus could escape from labs and infect humans. The research team in Wisconsin agreed to not publish certain details of their research after being requested to do so by a U.S. biosecurity panel.

The U.S. National Science Advisory Board for Biosecurity recommended that the studies done by Kawaoka’s group and a Dutch team led by Ron Fouchier of the Erasmus Medical Center not be published in full. The panel determined the risks of publishing the complete research would outweigh the benefits (Bio Prep Watch, 2012).

Title: Can Scientific Censorship Stop Bioterrorism?
Date: January 31, 2012
Source: Reason


Abstract: Today the U.S. National Scientific Advisory Board for Biosecurity recommended that the journals Nature andScience restrict publication about controversial new research relevant to the transmission of avian flu between humans. The fear: Would-be bioterrorists are combing the pages of the journals for tips on how to wreak havoc.

The H5N1 avian flu virus has killed 60 percent of the 600 or so people known to have come down with it since it was first identified in 1997. For comparison, seasonal flu in the United States kills about 0.1 0.003* percent of those who catch it. So far the H5N1 virus has not become easily transmissible between humans. But recently two research teams, one in the Netherlands and another in Wisconsin, reported that they had succeeded in transforming the virus into versions that are transmissible via respiratory drops through the air between mammals. In the normal course of scientific research, the teams approached the journals Science and Nature about publishing their results. Publication is the way that scientists get credit for their achievements and enable fellow researchers to benefit from and build upon their work.

Reports of this research, however, provoked worries that publishing the recipe for making the bird flu virus transmissible could enable bioterrorists to unleash a devastating global epidemic that could kill billions of people. The editorial page editors atThe New York Times are so frightened at the prospect that they have called on the researchers to destroy their new strains of the virus. Consequently, concerned journal editors and peer reviewers sought the advice of the U.S. National Scientific Advisory Board for Biosecurity (NSABB). In December, the NSABB recommended that the journals withhold research details to impede would-be bioterrorists.

In January, the two research teams agreed to a two-month moratorium on further research on their modified flu viruses. In addition, the World Health Organization is convening a meeting of prominent influenza researchers to discuss what should be done. Today, the NSABB is publishing its recommendation torestrict communication [PDF] of these scientific results inNature and Science.

A research moratorium is not new to the life sciences. Back in 1974, several prominent biologists concerned about the “potential biohazards”[PDF] posed by then new gene-splicing techniques published in leading scientific journals a call for a moratorium on certain kinds of experiments. A year later, a group of 140 scientists along with a few lawyers and journalists convened at Asilomar in California where they proposed a scheme for containing gene-spliced experimental organisms [PDF] in laboratories. This scheme evolved into laboratory regulations under the auspices of the National Institutes of Health. The NSABB cites this history, arguing, “We believe that this is another Asilomar-type moment for public health and infectious-disease research that urgently needs our attention.” That’s about right, but not necessarily in a good way.

The positive spin on history is that the 1974 research moratorium and the 1975 Asilomar meeting calmed public fears and enabled the new biotech research to proceed. Some participants now disagree, arguing that the fact that researchers had called for a moratorium instead inflamed the public. “I knew the [Asilomar] letter would give rise to a sort of fire-storm of ill-informed brave new world stuff,” said Asilomar participant and former New York Timesscience reporter Victor McElheny in 2009.

In fact, The New York Times in 1976 helped fan the flames of “brave new world stuff” by publishing an article, “New Strains of Life—or Death,” in which Cornell University biochemist Liebe Cavalieri warned that gene-splicing could lead to accidental outbreaks of infectious cancer. “In the case of recombinant DNA, it is an all or none situation—only one accident is needed to endanger the future of mankind,” warned Cavalieri. Forty years after the first gene-splicing experiments by biologists Paul Berg, Herbert Boyer, and Stanley Cohen, unregulated molecular biology experiments are common in high school biology classes and humanity is not yet afflicted with lab-made infectious cancers.

The NSABB research censorship recommendations provoke reflection on two general issues. First, governments, and especially defense bureaucracies, are addicted to secrecy [PDF]. Knowledge is power and government bureaucracies are in the business of accumulating and hoarding power. This is the opposite of science, which thrives in an atmosphere of transparency. While on very rare occasions there may be reasons to withhold temporarily scientific findings from the public, the default must always be openness.

The second issue is just how plausible is it that bioterrorists or hostile governments are eager to brew up and release a pandemic strain of deadly flu? The would-be bioterrorists would have no way to prevent it from infecting themselves, their families, friends, fellow citizens, and co-religionists. It’s possible that unleashing a pandemic might appeal to some kind of millenarian death cult, but your average terrorist and dictator are unlikely to conclude that a flu epidemic is a good idea. Bioterrorism using infectious agents is likely self-deterring.

On the other hand, even as the NSABB recommends secrecy and restriction, it acknowledges “that there are clear benefits to be realized for the public good in alerting humanity of this potential threat and in pursuing those aspects of this work that will allow greater preparedness and the potential development of novel strategies leading to future disease control.” First, avian flu is percolating out in nature, and there is every possibility that it will eventually mutate into a strain that infects people. The new research may have given public health officials a jumpstart on what to look for as they monitor changes in natural avian flu strains.

Second, researchers have been working on various treatments aimed at ameliorating or preventing avian flu among humans. These new air-transmissible strains could be used to see how effective current treatments may be and to guide the development of new treatments and vaccines.

Consider an earlier case of bioterrorism jitters provoked by publishing research on how to resurrect the Spanish flu. In 2005, researchers published the details of the viral strain that killed perhaps 50 million people in 1918. At the time some warned that the 1918 flu was “perhaps the most effective bioweapons agent now known.” However, as a result of the publication of that research we now know that that bioweapon fear was overblown.

As one of the lead researchers on the Spanish flu genome project, Peter Palese, recently pointed out, after publication lots of new researchers focused on the virus and happily discovered that it responds to seasonal vaccines and anti-flu drugs like Tamiflu and Symmetrel. “Had we not reconstructed the virus and shared our results with the community, we would still be in fear that a nefarious scientist would recreate the Spanish flu and release it on an unprotected world,” writes Palese. “We now know such a worst-case scenario is no longer possible.”

On January 25th, one of the lead avian flu researchers, Yoshihiro Kawaoka from the University of Wisconsin-Madison, argued in Nature that the research on transmissible avian flu must continue in order to protect people. Now that researchers know that avian flu can be transformed into transmissible strains, monitoring could facilitate eradication efforts and other countermeasures should such changes be detected in natural strains.

“The redaction of our manuscript, intended to contain risk, will make it harder for legitimate scientists to get this information while failing to provide a barrier to those who would do harm,”asserts Kawaoka. Spanish flu researcher Palese concurs, “The more danger a pathogen poses, the more important it is to study it (under appropriate containment conditions), and to share the results with the scientific community. Slowing down the scientific enterprise will not 'protect' the public—it only makes us more vulnerable.” Both are right.

The best defense against bioterrorism is the open and international scientific enterprise itself, not government recommended (and perhaps one day enforced) secrecy (Reason, 2012).

Title: Panel: Biologists Face Bioterror Risk "Crossroads"
Date: January 31, 2012
Source: USA Today

Abstract
: A federal advisory panel Tuesday warned microbiologists that their research now raises bioterror dangers akin to the proliferation risks faced by the early atomic scientists.

"We are in the midst of a revolutionary period in the life sciences," says the National Science Advisory Board for Biosecurity in a statement released by the journals Science and Nature. "However, there is also a growing risk that the same science will be deliberately misused and that the consequences could be catastrophic."

The panel of 22 senior scientists made headlines last month by requesting that the journals Science and Nature withhold details of two bird flu transmission studies from publication. The studies dealt with strains of the deadly flu able to transmit among ferrets, the closest animal models to humans. In the statement, the NSABB explains their decision, made at the request of the federal government:

"Our concern is that publishing these experiments in detail would provide information to some person, organization, or government that would help them to develop similar mammal-adapted influenza A/H5N1 viruses for harmful purposes. We believe that as scientists and as members of the general public, we have a primary responsibility "to do no harm" as well as to act prudently and with some humility as we consider the immense power of the life sciences to create microbes with novel and unusually consequential properties," says the statement.

The heads of the two study teams recently announced a two-month halt to their research for a World Health Organization symposium on the risks and benefits of the research. The NSABB panel compares the current moment in biology to ones faced before by atomic scientists and recombinant DNA researchers in the 1970's.

"The life sciences have reached a crossroads. The direction we choose and the process by which we arrive at this decision must be undertaken as a community and not relegated to small segments of government, the scientific community, or society. Physicists faced a similar situation in the 1940s with nuclear weapons research, and it is inevitable that other scientific disciplines will also do so," said the statement.

In a separate commentary, NSABB chief Paul Keim of Northern Arizona University in Flagstaff, further explained the panel's reasoning, calling for the scientific community as an international endeavor to decide on steps for controlling "dual-use" microbiological research. "What is gratifying and essential is that the debate is occurring; it is occurring on an international stage, and it is occurring rapidly," Keim said, in the statement released by the mBio journal (USA Today, 2012)

Title: Scientists Created Bird Flu Superbug That Could Set Off Next Global Pandemic
Date: Janaury 31, 2012
Source: Natural News

Abstract: During roughly the same time period that health experts worldwide have been warning that the infamous H5N1 avian flu virus could soon morph into a highly-transmissible, exceedingly-deadly "super strain" capable of killing millions, scientists from around the world have been exposed deliberately developing such a strain in laboratories.

Last month, we reported about research work conducted by Ron Fouchier from Erasmus Medical College in the Netherlands that had successfully created a super-deadly strain of H5N1. Fouchier and his colleagues had originally planned to publish their controversial findings in medical journals until the scientific community and many members of the public decried the research, calling for an immediate end to it.

Not only is the publishing of critical data about a deadly new strain of H5N1 a massive public health risk, but the research itself is a huge risk as well, as the strain could end up escaping from labs and quickly spreading around the world. Bio-terrorists could also gain hold of the strain -- or produce a similar one themselves -- to be used for starting the next global pandemic.

Whatever the case may be, it is all too coincidental that such research has been taking place for the past several years at the same time that authorities from around the world have been fear-mongering about how H5N1 could eventually mutate. As it currently stands, H5N1 has not naturally become more virulent. The only seriously virulent strains in existence right now are those deliberately created by scientists using public funds.

Opposition to Fouchier's work has continued so fervently since day one that he and his team have decided to temporarily halt any further research on their H5N1 strain, according to Russia Today. The damage has technically already been done, though, as the strain has already been created. However, details of the methodology used to create it have not been published, at least not yet.

Arguments in favor of Fouchier and the others research on H5N1 simply do not hold water, as they appear to offer nothing more than a convenient excuse for the intentional creation of a deadly, bio-weaponized viral strain. If and when the next global pandemic finally does arrive, in other words, we will all know who to blame if it happens to be a mutated form of H5N1 (Natural News, 2012).

Title: No Way Of Stopping Leak Of Deadly New Flu, Says Terror Chief
Date: February 8, 2012
Source: Independent


Abstract: 
The bioterrorism expert responsible for censoring scientific research which could lead to the creation of a devastating pandemic has admitted the information "is going to get out" eventually.

Professor Paul Keim, chairman of the US National Science Advisory Board for Biosecurity, controversially recommended that researchers be stopped from publishing the precise mutations needed to transform the H5N1 strain of birdflu virus into a human-transmissible version.

In an exclusive interview with The Independent, he argued it had been necessary to limit the release of the scientific details because of fears that terrorists may use the information to create their own H5N1 virus that could be spread easily between people.

Professor Keim said that it was necessary to slow down the release of scientific information because it was clear that the world is not yet prepared for a strain of highly lethal H5N1 influenza that can be transmitted by coughs and sneezes.

“We recognised that, in the long term certainly, the information is going to get out, and maybe even in the mid term. But if we can restrict it in the short term and motivate governments to start getting busy in terms of building up the flu-defence infrastructure, then we’ve succeeded at a certain level,” he said.

“If we can slow down the release of the specific information that would enable somebody to reconstruct this virus and do something nefarious, even for a while, then that was a good thing.”

By withholding key details of the mutations needed to make an airborne strain of H5N1, this would give time for governments to prepare for and prevent a possible pandemic, he added.

“The infrastructure to stop a pandemic in this area is not there. We just don’t have the capabilities. The very first time we knew that the swine flu virus [coming out of Mexico] was there, it was already in 18 countries. I’m not confident at all that we have the surveillance capability to spot an emerging virus in time to stop it,” he said.

“And even if we did spot it early on, I don’t think we have sufficient vaccines. The vaccines aren’t good enough, and the drugs are not good enough to stop this emerging and being a pandemic.”

Although H5N1 spreads rapidly between birds, it has so far affected only about 600 people worldwide who have had direct contact with infected poultry. However, two teams of researchers have shown independently that it only requires five mutations for H5N1 to become an airborne pathogen for laboratory ferrets, the standard animal model for human influenza.

Professor Keim said that the biosecurity board was asked by the US Government to review the two independent studies because they had already been submitted to the journals Science and Nature. The board had to make a recommendation on whether any or all of the information should be published.

Scientists involved in showing how the H5N1 birdflu virus can be transmitted in the air between ferrets have criticised the biosecurity board’s decision to part-censor their research on the grounds that it would hinder the development of new vaccines and drugs.

However, Professor Keim dismissed the criticism as disingenuous. “The argument that we need this information to make better vaccines and better drugs does not ring true,” he said. “There are lots of ways to make drugs against this virus. The very drugs they were using against this virus were the very same ones used against other flu viruses. The drug-invention problem has nothing to do with having this virus to hand,” he added.

Professor Keim revealed that although he is personally in favour of the research that led to the creation of airborne strains of H5N1, some other members of the board were not convinced. “I’m personally in favour of this research but that opinion is not universal on the board. Some people on the board wanted to stop this research and destroy the virus,” he said.

“I don’t think we need this virus to prove that Tamiflu works against it. And we know that the H5 antigen is not a great antigen for vaccines, we don’t need the virus to tell us that. But there are some experiments that can only be done with the live virus and I’m in favour of keeping the virus for those type of experiments” (Independent, 2012)

Title: Despite Safety Worries, Work On Deadly Flu To Be Released
Date: February 18, 2012
Source: New York Times

Abstract: The full details of recent experiments that made a deadly flu virus more contagious will be published, probably within a few months, despite recommendations by the United States that some information be kept secret for fear that terrorists could use it to start epidemics.

The announcement, made on Friday by the World Health Organization, follows two months of heated debate about the flu research. The recommendation to publish the work in full came from a meeting of 22 experts in flu and public health from various countries who met on Thursday and Friday in Geneva at the organization’s headquarters to discuss “urgent issues” raised by the research.

Most of the group felt that any theoretical risk of the virus’s being used by terrorists was far outweighed by the “real and present danger” of similar flu viruses in the wild, and by the need to study them and freely share information that could help identify the exact changes that might signal that a virus is developing the ability to cause a pandemic, said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, who represented the United States at the meeting.

The natural form of the virus being studied has infected millions of birds, mostly in poor countries in Asia, and although it does not often infect people, it has a high death rate when it does. If the virus were to develop the ability to infect humans more easily, and to spread from person to person — which it almost never does now — it could kill millions of people.

“The group consensus was that it was much more important to get this information to scientists in an easy way to allow them to work on the problem for the good of public health,” Dr. Fauci said. “It was not unanimous, but a very strong consensus.”

But the United States was not part of that consensus, Dr. Fauci said. He said he still agreed with the National Science Advisory Board for Biosecurity, which recommended in December that the research be published only in a redacted form, for safety reasons.

The experiments involve a type of bird flu virus known as H5N1. Of about 600 known cases, more than half have been fatal. The exact death rate is not known, however, because some deaths may go uncounted and mild cases may go undiagnosed. But whatever the death rate turns out to be, most researchers think it will be significantly higher than that of any flu virus, even the notorious 1918 flu, which had a death rate of about 2 percent. The 1918 virus, however, was highly contagious, and killed as many as 50 million people worldwide.

The H5N1 work, paid for by the National Institutes of Health, was done by two separate research teams, at Erasmus Medical Center in Rotterdam, the Netherlands, and at the University of Wisconsin-Madison.

Research on the viruses was voluntarily suspended by the researchers last month because of the uproar it provoked. News of the experiments, which were conducted last year, set off public fears that the virus could accidentally leak out of a laboratory, or be stolen by terrorists, and result in a devastating pandemic. Scientists have been divided, with some urging that the results be published in full, and others saying the research is so dangerous that it should never even have been done, much less published.

The moratorium on the research and its publication will be extended, probably for several months, according to Dr. Keiji Fukuda, the health organization’s assistant director general for health security and the environment, who spoke at a news conference after the two-day meeting in Geneva.

Dr. Fukuda said that the moratorium would give researchers and officials an opportunity to provide better information to the public about the research and its importance, and would also give safety experts a chance to assess the conditions in which the work is being done.

For now, he said, the group agreed that it was “best that these viruses should stay where they are — in well-run high-security labs.”

The researchers in the Netherlands and Wisconsin made genetic changes in the virus that made it transmissible through the air among ferrets, an animal considered a good model for the way flu behaves in humans. It is not known whether the new virus would be equally contagious in people.

Bruce Alberts, editor of the journal Science, said his journal and another one, Nature, had been planning to publish redacted versions of the research in mid-March. Now, Dr. Alberts said, they will wait until it is considered appropriate to publish the full versions. He said he was surprised that the group meeting in Geneva had reached a decision so promptly (New York Times, 2012).

Title: Deadly Bird Flu Studies To Stay Secret For Now: WHO
Date: February 17, 2012
Source: Reuters

Abstract: Two studies showing how scientists mutated the H5N1 bird flu virus into a form that could cause a deadly human pandemic will be published only after experts fully assess the risks, the World Health Organization (WHO) said on Friday.

Speaking after a high-level meeting of flu experts and U.S. security officials in Geneva, a WHO official said an deal had been reached in principle to keep details of the controversial work secret until deeper risk analyses could be carried out.

"There is a preference from a public health perspective for full disclosure of the information in these two studies. However there are significant public concerns surrounding this research that should first be addressed," said Keiji Fukuda, the WHO's assistant director-general for health security and environment.

The WHO called the meeting to break a deadlock between scientists who have studied the mutations needed to make H5N1 bird flu transmit between mammals, and the U.S. National Science Advisory Board for Biosecurity (NSABB), which wanted the work censored before it was published in scientific journals.

Biosecurity experts fear mutated forms of the virus that research teams in The Netherlands and the United States independently created could escape or fall into the wrong hands and be used to spark a pandemic worse than the 1918-19 outbreak of Spanish flu that killed up to 40 million people.

WHO spokesman Gregory Hartl said that because of these fears, "there must be a much fuller discussion of risk and benefits of research in this area and risks of virus itself."

But a scientist close to the NSABB who spoke to Reuters immediately after the decision said the board was deeply "frustrated" by the situation.

The only NSABB member attending the meeting was infectious disease expert Paul Keim of Northern Arizona University and he "got the hell beat out of him," the source said.

"It was a closed meeting dominated by flu people who have a vested interest in continuing this kind of work," he added.

The WHO said 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-linked laboratories specializing in influenza.

High Fatality Rate

The H5N1 virus, first detected in Hong Kong in 1997, is entrenched among poultry in many countries, mainly in Asia, but so far remains in a form that is hard for humans to catch.

It is known to have infected nearly 600 people worldwide since 2003, killing half of them, a far higher death rate than the H1N1 swine flu which caused a flu pandemic in 2009/2010.

Last year, two teams of scientists - one led by Ron Fouchier at Erasmus Medical Center and another led by Yoshihiro Kawaoka at the University of Wisconsin - said they had found that just a handful of mutations would allow H5N1 to spread like ordinary flu between mammals, and remain as deadly as it is now.

This type of research is seen as vital for scientists working to develop vaccines, diagnostic tests and anti-viral drugs that could be deployed in the event of an H5N1 pandemic.

In December, the NSABB asked two leading scientific journals, Nature and Science, to withhold details of the research for fear it could be used by bioterrorists.

They said a potentially deadlier form of bird flu poses one of the gravest known threats to the human population and justified the unprecedented call to censor the research.

The WHO voiced concerns, and flu researchers from around the world declared a 60-day moratorium on January 20 on "any research involving highly pathogenic avian influenza H5N1 viruses" that produce easily contagious forms.

Dr. Bruce Alberts, editor-in-chief of the journal Science, said it is now likely the paper submitted to Science and to the journal Nature will be published in full.

Alberts said it is still not clear how the scientists in Geneva plan to handle biosafety issues mentioned by the group, and it is still not clear when the papers will be published, but it will likely not be years.

"I hope this does not cause the world governments and WHO to stop working on this problem," Alberts said of any potential fallout from the decision at a news briefing at the American Association for the Advancement of Science meeting in Vancouver.

When asked how the journal is safeguarding copies of the as-yet-unpublished paper, he said it is in a locked electronic file and is password protected. And the magazine has asked reviewers of the paper to destroy their review copies.

Fouchier, who took part in the two-day meeting at the WHO which ended on Friday, said the consensus of experts and officials there was "that in the interest of public health, the full paper should be published" at some future date.

"This was based on the high public health impact of this work and the need to share the details of the studies with a very big community in the interest of science, surveillance and public health on the whole," he told reporters.

In its current form, people can contract H5N1 only through close contact with ducks, chickens or other birds that carry it, and not from infected individuals.

But H5N1 can acquire mutations that allow it to live in the upper respiratory tract rather than the lower, and the Dutch and U.S. researchers found a way to make it travel via airborne droplets between infected ferrets. Flu viruses are thought to behave similarly in the animals and in people.

Asked about the potential bioterrorism risks of his and the U.S. team's work, Fouchier said "it was the view of the entire group" at the meeting that the risks that this particular virus or flu viruses in general could be used as bioterrorism agents "would be very, very slim".

"The risks are not nil, but they are very, very small" (Reuters, 2012).

Title: CDC Warns That New Swine Flu Strain Has 'Pandemic Potential'
Date: February 22, 2012
Source: Chicago Tribune

Abstract: A paper published Tuesday by scientists at the Centers for Disease Control suggests a new swine flu virus has the potential to cause an outbreak.

The A(H3N2)v swine flu strain that has infected at least 18 Americans since Sept. 2010 has shown the potential for human-to-human transmission. According to the paper, which was published in the Proceedings of the National Academy of Sciences, the H3N2 strains "resemble viruses with pandemic potential." Terrence Tumpey, one of the authors of the study, says the current seasonal flu vaccine won't protect against this swine flu strain, although he says the CDC is working on creating a vaccine for swine flu variants such as the one he studied.

In November, the CDC suggested that "limited human-to-human transmission" of H3N2 had occurred in Iowa, but the most recent findings show that the virus is more easily transmissible than originally thought, leading the authors to warn that "swine-origin H3N2 viruses have the potential to cause additional human disease." Since August, people in at least five states (Indiana, Iowa, Maine, Pennsylvania and West Virginia) have caught the strain.

The paper warns that people born after the mid-1990s may be "particularly susceptible to infection" because of a virus that circulated in the early part of that decade that may have given some people a low level of protection.

The virus was shown to be highly transmissible from ferret to ferret, an animal which has long been used to explore the possibility of human-to-human transmission of viruses.

"The use of the ferret model has become indispensable for understanding the virulence and transmission of influenza viruses, partly because ferrets and humans share similar lung physiology," the paper says.

The CDC hasn't received any new reports of infection since December, which has scientists stumped.

"I wish we had a good answer for why it hasn't taken off in humans. We don't fully understand the factors involved," Tumpey says.

The resulting flu from H3N2 viruses have generally been more severe than seasonal flu viruses, according to Tumpey. "Overall, the cases have been fairly mild, but there have been a few cases of hospitalization," he says.

From mid-August to late December 2011, the CDC received 12 reports of human infections from H3N2. The CDC has not reported any additional cases in 2012, but last week the organization warned that the 2012 season is the "latest flu season in nearly three decades" and that America will likely see more infections in the coming weeks.

"We've been lucky nothing has occurred so far in 2012," he says. "This study underscores the need for continued public health surveillance" (Chicago Tribune, 2012).

Title: Censoring Data On Influenza Could Increase Bioterror Threat
Date: April 9, 2012
Source: Bio Prep Watch


Abstract: The attempt to censor science by redacting scientific research may cause the very bioterrorism problems it is trying to prevent, a a leading cyber-security specialist has revealed.

Bruce Schneier, the chief security technology officer for the London-based telecommunications firm BT, spoke before a meeting of flu and security experts last week at the Royal Society in London. He warned the assembled experts that the redaction could lead to additional bioterrorism problems, New Scientist reports.

The meeting came in the wake of a decision by the U.S. National Science Advisory Board for Biosecurity to publish two scientific papers reporting on an H5N1 flu strain that spreads among mammals. The board previously called to have details omitted from the papers so that bioterrorists would not be able to construct the viruses themselves. The board changed its mind, but the U.S. government published a policy regulating such research in March.

Schneier said that computer hackers are not likely to search the internet looking for random files related to science to hack into.

“If no one knows about it, it’s safe,” Schneier said, according to New Scientist. “If you announce that you have sensitive information by putting out a redacted paper, then if someone wants to know, they will. Any computer can be hacked.”

Schneier emphasized that he was talking about both scientific papers being hacked along with experimental notes and data kept electronically in laboratories (Bio Prep Watch, 2012).

Title: NSABB Calls For International Biosecurity Guidelines
Date: April 20, 2012
Source: Bio Prep Watch

Abstract: The top U.S. government biosecurity committee recently called for the development of international guidelines to guide research on dangerous flu strains.

In the wake of the controversy surrounding the publication of studies by two independent teams who created strains of H5N1 influenza transmissible in ferrets, the U.S. National Science Advisory Board for Biosecurity proposed talks to draft global guidelines for conducting and communicating potentially dangerous work, according to NewScientist.com.

“The US government and others are going to have to come up with a credible plan for limited distribution of information, when the next, last-minute review points to the need for this,” David Relman of Stanford University said, NewScientist.com reports.

The NSABB originally requested that some of the results of the two studies not be published. In early April, the advisory board reversed its original findings in light of more information supplied about the results and ramifications of the work.

Relman was one of six members of the NSABB who did not vote for the reversal. The dissenters said that the research could enable misuse. They pointed out that the new strains are airborne and just as pathogenic as the parent H5N1 strain.

Michael Osterholm of the University of Minnesota also dissented. In a confidential letter leaked to the journal Science, Osterholm said that the new information presented to the board was biased towards publication. He said that the board did not consider the chances that well-meaning scientists could attempt to repeat the experiments without adequate biosafety measures 
(BioPrep Watch, 2012).

Title: Science Journal Could Give Recipe For Deadly Avian Flu Virus
Date: May 14, 2012
Source:
CNN

Abstract: 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.

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 studyand 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.

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" (CNN, 2012).

Title: Senate Committee Calls For More Oversight On Risky Biological Research
Date: April 27, 2012
Source: Bio Prep Watch


Abstract: Senators raised concerns about oversight issues on government funded biological research at a Thursday hearing of the Senate Committee on Homeland Security and Governmental Affairs.

“When the American people pay for scientific research intended for the common good, they have a right to expect that their money will not be used to facilitate terrorism,” Senator Susan Collins (R-Maine) said, referring to the recent controversy surrounding NIH funded research to create a highly contagious airborne form of the H5N1 bird flu virus. “These are not hypothetical threats.”

Democrats and Republicans both stressed the importance of enacting more oversight for any sort of dual use research.

“We need to put in place better systems to track this kind of research at each experimental stage rather than waiting till its ready for publication to make decisions about what can or can’t be revealed,” Senator Joseph Lieberman (I-Conn.) said.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Disease, and Dr. Paul Keim, the chair of the National Science Advisory Board for Biosecurity, agreed with the senators’ remarks, but also warned against the possibility of regulatory oversight stifling future research.

“It is critical that we establish policy that intensely monitors high potential dual use research of concern from cradle to grave in order to protect us from misuse, but also to free low-potential DURC research from onerous regulations,” Keim said (Bio Prep Watch, 2012).

Title: Designer Flu
Date: June 2, 2012
Source:
ScienceNews

Abstract: Last summer, scientists performed an experiment that could have been ripped from the script of a Hollywood thriller. Sealed off in high-tech laboratories in the Netherlands and Wisconsin, researchers transformed one of the world’s most deadly viruses, transmissible by direct contact, into versions capable of spreading through the air.

Unlike in the movies, news of the lab-made viruses was not delivered as a threat, and the scientists doing the work weren’t henchmen of an evil dictator or members of a shadowy terrorist organization. Instead, the researchers were on the good-guy team — respected academics investigating how a type of flu virus that typically targets birds might become contagious in people.

Though the avian flu virus known as H5N1 infects and kills mostly birds — including chickens, turkeys and waterfowl — it has sickened more than 600 people worldwide since an outbreak in Hong Kong in 1997, killing about half of them. The virus doesn’t pass easily from person to person even with close contact, let alone through the air. Most victims contracted it after handling infected birds or from contaminated environments.

But the Netherlands and Wisconsin research teams created their airborne versions of the virus in attempts to determine whether the virus could become easily transmissible among people. Knowing more about the virus’s potential to make such a change might help public health workers spot a budding pandemic, and even point to ways to head off such a global catastrophe.

Yet even though the researchers undertook the work for noble reasons, they soon found themselves as embroiled in intrigue and worldwide controversy as any fictional villains. Since the Dutch researchers announced the work at a scientific meeting in Malta in September, their saga has featured closed-door meetings, security reviews, publishing restrictions, a voluntary halt on the research, a media frenzy that included a flurry of opinion pieces by other scientists and even threats of imprisonment. The Wisconsin team’s story has played out similarly, only with slightly less drama. At issue is the danger posed by the lab-made versions of air-transmissible H5N1 and who should know how they were created.

Each team submitted a paper to a major scientific journal — one toNature and one to Science — containing step-by-step instructions for turning H5N1 into an airborne virus, including information about the changes in the genetic instruction book important for the transformation. Initially, a U.S. government advisory board charged with determining whether the research was fit to print decided that open publication posed too great a risk of misuse, recommending the publication of severely redacted versions. Critics siding with the board warned that terrorists or rogue nations could use the information to re-create the viruses and unleash them on the world.

Proponents of publishing argued that public health workers need to know which mutations spell trouble in case those mutations are spotted in the wild. At the end of March, the board reversed its decision, ruling — after some clarifications — that the benefits of information sharing outweighed the risks.

One paper has now been published in a full-length version inNature (SN Online: 5/2/12); as of mid-May, the second was still in the peer review and editing process. (Editor’s note: The second paper was published in the June 22 ScienceClick here for news story.) But the controversy the papers ignited has made flu virus research, and the issues of national security and data sharing that come along with it, topics of debate over lab benches and dinner tables.

Before it was clear that the papers would ever see print, they were called “the two most famous unpublished manuscripts in modern life science history” by Michael Osterholm, director of the Minnesota Center of Excellence for Influenza Research and Surveillance in Minneapolis.

Flu-id Rulings
Osterholm serves on the 23-member National Science Advisory Board for Biosecurity, NSABB for short, charged with assessing whether the H5N1 papers should be published. Established in 2004, the board evaluates biological research that could be used for nefarious purposes. Such “dual-use” research is generally performed to uncover the basic biology of disease-causing organisms for medical or public health purposes, but could be twisted by people with evil intentions into biological weapons.

In its history, the board has reviewed six other scientific papers, in all cases recommending publication with no changes or only minor modifications, says Paul Keim, an anthrax researcher at Northern Arizona University in Flagstaff who chairs the advisory board.

But in the case of the two H5N1 flu papers, “The full board recommended that neither manuscript be published with complete results,” Keim said April 3 in London at a meeting organized by the Royal Society and other groups. “The board found that these results had an unusually high magnitude of risk.”

Knowing all the details of the research could allow someone to skip years of work and quickly make a transmissible version of the virus, the advisers concluded after first reviewing the papers in November.

What made some board members so uncomfortable — and what the media quickly picked up on — was the nature of the virus. To call H5N1 deadly is putting it mildly. The virus kills an estimated 59 percent of the people it infects.

Though some studies say the actual kill rate is far lower, “Even if it is 20 times lower, it would still have a mortality rate that far exceeds that of the 1918 flu,” says Osterholm. That pandemic racked up a body count of tens of millions of people worldwide.

“People like myself have almost been ridiculed for our position on the risks of the influenza virus,” Osterholm says. If smallpox or SARS were ever to escape from a lab and start infecting people, it would be bad but could easily be brought under control, he says. “Influenza is very different. Influenza is like having one screen door on your submarine. It will sink you.”

So telling the general public, including potential terrorists, how to make an airborne version of highly lethal H5N1 was, at least at first, deemed a risk that outweighed the public health benefit of publication.

But other scientists were outraged by the decision, which they saw as holding back essential information. The papers show that although H5N1 has been around for 15 years and has not yet developed the ability to spread easily from person to person, it could be just a few mutations away from becoming a human-transmissible virus. Full disclosure about the steps required for that transformation could be key to finding viruses already heading down that path in the wild.

The Netherlands group, headed by Ron Fouchier of Erasmus Medical Center in Rotterdam, found that five mutations are enough to make the virus infectious through airborne particles in ferrets, which are often used as stand-ins for humans in infectious disease experiments. At the Royal Society meeting, Fouchier was unable to discuss details about the type of mutations that his group found because of Dutch restrictions on the export of dual-use research. (Fouchier’s team has since been granted an export license.)

But the United States had already lifted a similar ban, giving Yoshihiro Kawaoka of the University of Wisconsin–Madison the go-ahead to present his team’s results in full. Kawaoka’s team also reported its findings online May 2 in Nature.

Strictly speaking, the Wisconsin group’s transmissible virus is not H5N1 bird flu virus. Instead it is a composite of H5N1 and the H1N1 “swine flu” virus that caused a pandemic in 2009. To create the combination virus, the researchers replaced a sugar-spiked protein called hemagglutinin (the H in H5N1) found in the 2009 virus with one from the bird flu virus. Hemagglutinin studs the flu virus’s outer envelope and helps the virus grab and invade cells. Although the researchers genetically engineered the bird/swine combination virus in the lab, the experiment mimicked the sort of parts-swapping that influenza viruses often go through in nature.

Merely swapping hemagglutinins wasn’t enough to make the composite virus into an airborne infectious flu in ferrets, though. The original combination virus didn’t pass between ferrets in neighboring cages. Researchers helped the virus along by transferring it directly from one ferret to another. In ensuing rounds of researcher-assisted ferret infections, mutations cropped up in the hemagglutinin protein.

At least four changes to the molecule were needed to make the virus readily transmit via airborne droplets, the researchers found. Three of the mutations, all located in a part of the protein needed to attach to cells, switched the virus from one that could latch onto cells in the digestive tract of birds and the lungs of mammals to one that also could hang on in mammalian upper respiratory tracts. Grabbing on in that region is necessary for virus particles to spread via coughing and sneezing.

A fourth change in hemagglutinin may affect how well the virus can fuse with cells in ferret — and presumably human — hosts. That mutation makes the hemagglutinin more stable and allows the virus to replicate better in mammalian cells, Kawaoka said.

A group of influenza researchers and public health officials convened by the World Health Organization, after hearing the results presented in February, concluded that this information would be valuable for public health workers. A full accounting of the data would aid surveillance teams in identifying naturally occurring mutations that indicate H5N1 is becoming less of a bird virus and more of a human virus, proponents of publishing said. Besides, the WHO panel concluded, there is no currently feasible way to withhold the data from most of the world while still quickly disseminating the information to those who really need to know it.

One of the mutations Kawaoka found in the hemagglutinin molecule may already be helping the virus adapt to humans. In Egypt, 219 H5N1 viruses taken from birds had the mutation, called N158D, while 87 H5N1 viruses isolated from birds did not. All 46 H5N1 viruses isolated from humans carried the mutation, suggesting that the genetic change is important for the virus to infect humans.

And during the Royal Society meeting, Fouchier said that when his data are put alongside Kawaoka’s, a pattern emerges that begins to reveal which biological traits an influenza virus needs to become a pandemic strain. It’s the ability to spot the trends in virus evolution that makes publishing this kind of information so important, the researchers argued. Even if surveillance measures aren’t enough to catch the virus before it becomes a pandemic, Fouchier said, knowing how it is likely to happen will allow researchers to design vaccines and antiviral medications to combat a future pandemic.

Deadly or Not
One reason that the cons of publishing may have initially appeared to outweigh the pros is that the findings were hyped. Part of that hype came from the researchers themselves. Fouchier was quoted on Science’s website as saying that the virus created in his lab is “probably one of the most dangerous viruses you can make.” Scientists as well as members of the media and public interpreted that statement and other remarks Fouchier made to mean that the team’s lab-made virus retained its killing capacity as it gained the ability to pass from ferret to ferret. The research done by Kawaoka’s team was painted with the same scary brush, even though no ferrets died in those experiments.

But it turns out that the lab-made viruses are neither as deadly nor as transmissible as many people had initially believed.

“What the world thought isn’t exactly what happened,” says Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases in Bethesda, Md.

Since the advisory board’s original decision was handed down, Kawaoka and Fouchier have been trying to set the record straight, giving detailed presentations to the World Health Organization and at the advisory board meeting at the end of March. The teams rewrote their papers giving more details about the viruses’ transmissibility and lethality (thanks to journal editors at Natureand Science who relaxed word-count restrictions). The additional information, rewritten papers, face-to-face meetings with the researchers and a new comprehensive U.S. government policy on how to handle dual-use research tipped the board’s risk-benefit balance and the board reversed its initial decision. On March 30 the board voted to allow the details of the papers to be published in full.

Keim said that the data in the first versions of the papers have not been changed, but that the presentations and interpretations have. The original version of Fouchier’s paper, for instance, highlighted the virus’s lethality when it was put directly into ferrets’ tracheae.

The mutant, transmissible form of the virus killed one of eight animals and only when delivered in high doses into the trachea, Fouchier explained following the board’s initial decision.

“It’s absolutely clear that H5N1 is a highly pathogenic virus for chickens,” Fouchier said. “You inoculate a chicken, the chicken will drop dead.” And high doses of the virus put directly into the lungs will kill a ferret in three days. But inoculating the viruses into ferrets’ tracheae is another story. Most develop the common symptoms of ferret flu — ruffled fur, loss of appetite and lethargy. “They might get a little bit of flu,” he said, “but they certainly do not drop dead.”

Ferrets that contracted the virus from other ferrets’ sneezes also didn’t die. “It’s certainly not highly lethal if ferrets start coughing and sneezing at one another,” Fouchier said.

A second misconception centered on how well the virus spread. Media reports said that “the virus would spread like wildfire if it came out of our facility,” Fouchier said. “But we do not think this is the case.”

His team’s transmissible, quintuple mutant version of H5N1 appears to spread less efficiently than the 2009 pandemic swine flu strain. “This is a lousy transmitter at this stage still,” he said. He cited several pieces of evidence indicating that the virus doesn’t spread well, including that fact that animals infected with the mutant H5N1 made few infectious particles. The quantity of such particles is important because the dose of a virus people are exposed to can influence how sick they get.

What’s more, ferrets previously exposed to seasonal flu were completely protected from severe disease when given the team’s airborne H5N1. A group of researchers in Belgium reported in 2009 in Vaccine that being infected with an H1N1 virus gives pigs partial protection against H5N1. Extending those findings to humans, Fouchier said people who have caught seasonal flu would have some protection against H5N1. “Very few individuals would actually develop severe disease, but would actually be protected by cross-protective immunity.”

Osterholm disputes the claim that immunity to other flu viruses will protect people from H5N1. “There is no data in the human experience to support that,” he says. Contracting one year’s seasonal flu strain doesn’t protect people from next year’s version of the virus, so there’s no reason to think that getting other flu strains or flu vaccines will protect people from H5N1, he said.

The argument that the Fouchier team’s virus isn’t so deadly doesn’t convince Osterholm that proceeding with publication is a good idea, either. Osterholm, who was one of the minority of members that voted at the advisory board’s March meeting to withhold data from the Dutch group’s paper, says he is more worried about the virus’s ability to spread. Even low transmissibility is bad: If a terrorist were to let such a virus loose, it may start recombining with seasonal flu strains to produce yet more nasty, pandemic strains.

Information Revelation
Some scientists, Adolfo García-Sastre included, think concerns over terrorists making a lab-made replica are overblown. García-Sastre, a microbiologist at Mount Sinai School of Medicine in New York City who specializes in influenza biology, was part of a team that resurrected the 1918 flu virus in the lab and reported the feat inScience in 2005. “One could argue that the same thing could have happened when we re-created 1918, but nobody has done it,” he says.

That paper is the only one of the six the advisory board has reviewed that Osterholm now regrets not holding back from publication. The thought at the time was that people would already have immunity to H1N1 viruses, such as the 1918 virus, because many seasonal flu strains are similar. It was only when the 2009 H1N1 pandemic hit that he and others realized they had been wrong, he says. He doesn’t want to repeat the mistake with H5N1, and making the Dutch team’s paper fully available could be just such a mistake.

But others say even if it is a mistake, it’s been made before — information about creating a more dangerous H5N1 virus is already out there. Researchers from the U.S. Centers for Disease Control and Prevention in Atlanta and the Scripps Research Institute in La Jolla, Calif., reported in the Jan. 5 Virology that they had made a more transmissible form of the virus. The researchers mutated the hemagglutinin from H5N1 and found that three mutations, including one known as Q226L that was also found in the Wisconsin study, were enough to make the virus able to pass via direct contact from ferret to ferret. But those researchers did not make a fully airborne version of the virus.

Many more changes would be required to achieve a version of H5N1 that could transmit easily between people, the CDC and Scripps team speculated. But the researchers may have been closer than they thought. This paper was not reviewed by the biosecurity advisory board.

“That was startling because we did not know it was in the works until it appeared,” Keim said.

Both Kawaoka’s and Fouchier’s groups have also previously published papers describing mutations found in H5N1 in the wild that allowed the virus to bind to cells in the upper respiratory tract, including mutations in some viruses isolated from infected people.

Almost anybody who has training in virology and molecular biology and the specialized skills to grow influenza viruses in the laboratory could, with instructions, replicate the viruses that these two teams created, García-Sastre admits. “But the same people who have this training can make this happen without knowing this information.”

The techniques the two groups used are common, and other researchers could use similar methods to develop their own version of an airborne H5N1. So withholding data about the mutations doesn’t make people any safer, García-Sastre argues. “I don’t want to say that everything should be published,” he says. “If someone stumbles upon something that no one could have predicted, or used techniques no one would have thought would result in a very dangerous virus, I think that should not be published.”

Most everyone agrees that eventually there will be a dual-use research paper that may be far too dangerous to publish. But for now, the power of public health information sharing has trumped biosecurity concerns.

After both famous manuscripts have had their day in print, the debate over dual-use research in general may be set aside. That’s exactly what many people don’t want to happen. Researchers, journal publishers and government officials have all urged that a mechanism for dealing with potentially dangerous information needs to be put in place before the next scary paper comes along.

That may happen sooner rather than later: Some reports suggest Fouchier’s ferret research uncovered yet another mutation in H5N1, one that may make the virus even more transmissible. 

Screenwriters are already penning a sequel.

Biosecurity Blowback
When two papers reporting lab-made infectious bird flu entered the limelight last year, they stirred up policy issues that went far beyond the question of to be or not to be published.

If the details of the studies were redacted, for example, then who should get to see the information? Currently there is no plan in place for identifying who deserves access to data of this type for public health purposes or for delivering the content in confidence. It is not even clear who has the authority to oversee such a data-distribution system. In the case of both flu papers, government agencies in the United States and the Netherlands decided — to the surprise of the researchers — that export restrictions applied to the scientific data.

Concerns also surfaced about what a precedent of redaction would mean for the future of public health science. Currently, countries share their viruses with the research world under the assumption that they will have access to any findings. Without access, those countries might not be so generous. And then there is the importance of publication to a scientific career: A precedent of redaction might dissuade scientists from tackling topics that mingle with biosecurity. An independent evaluation of one of the flu papers, commissioned by Nature, concluded that “pushing the best scientists towards blander areas in which they can more easily publish must increase our vulnerability” to diseases for which no countermeasures exist.

Other questions stemmed from the nature of the research itself. Canada has passed a regulation requiring that transmissible H5N1 human research be conducted at a Biosafety Level 4 lab, the highest designation, which requires scientists to work in space suits inside fully sealed facilities in which nothing gets in or out without sterilization (Level 4 lab shown). Such precautions are hard to come by in many countries where H5N1 is a problem.

Some people have even questioned whether this type of research should be done at all, or have suggested that policy concerns be addressed before studies move forward. In response, on March 29, the U.S. government issued a new, comprehensive policy for overseeing research on avian influenza and 14 other pathogens. This “cradle to grave” policy, as biologist Paul Keim calls it, would require scientists, institutions and funding agencies to take early steps to minimize risks to people, animals or plants. If risks can’t be mitigated, the government could classify the research or pull funding (ScienceNews, 2012)

Title: Second Bird Flu Study Published After Terrorism Debate
Date: June 21, 2012
Source:
Fox News

Abstract: The second of two bird flu studies once considered too risky to publish was released Thursday, ending a saga that pitted concerns about terrorism against fears of a deadly global epidemic.

Both papers describe how researchers created virus strains that could potentially be transmitted through the air from person to person. Scientists said the results could help them spot dangerous virus strains in nature.

But last December, acting on advice of a U.S. biosecurity panel, federal officials asked the researchers not to publish details of the work, which identified the genetic mutations used to make the strains. They warned the papers could show terrorists how to make a biological weapon.

That led to a wide-ranging debate among scientists and others, many of whom argued that sharing the results with other researchers was essential to deal with the flu risk.

Bird flu has spread among poultry in Asia for several years and can be deadly in people, but it only rarely jumps to humans. People who get it usually had direct contact with infected chickens and ducks. Scientists have long worried that if the virus picked up mutations that let it spread easily from person to person, it could take off in the human population, with disastrous results.

The two teams that conducted the controversial research eventually submitted revised versions of their papers to the federal biosecurity panel. They said the changes focused on things like the significance of the findings to public health, rather than the experimental details themselves.

The panel announced in March it supported publishing the revised manuscripts, saying it had heard new evidence that sharing information about the mutations would help in guarding against a pandemic. It also concluded that the data didn't appear to pose any immediate terrorism threat. The government agreed in April.

The benefit of scientists sharing data from the new paper "far outweighs the risk," Dr. Anthony Fauci, director of the National institute of Allergy and Infectious Diseases, said Wednesday.

One paper, from Yoshihiro Kawaoka of the University of Wisconsin-Madison and colleagues, was published last month by the journal Nature. On Thursday, the journal Science published the second paper, from a team led by Ron Fouchier of the Netherland's Erasmus Medical Center in Rotterdam.

Both papers tested the ability of the altered bird flu viruses to spread through the air between ferrets, none of which died from those infections. The Fouchier paper reports that the virus could spread this way by acquiring as few as five specific mutations.

Two of those mutations are already found frequently in strains of the virus. And the other three could arise during infection of people or other mammals, a new mathematical analysis in Science concluded. But the likelihood is unclear. An author of the analysis compared the situation to earthquake prediction.

"We now know we're living on a fault line," Derek Smith of Cambridge University and the Erasmus center told reporters. "It's an active fault line. It really could do something."

Fouchier said the ferret results don't give a clear answer about how deadly an altered virus would be in people.

Eddy Holmes of Penn State University, who studies the evolution of flu viruses but did not participate in the Fouchier or Kawaoka studies, said those works present the first good experimental evidence about how the bird flu virus could mutate to become more easily spread between people.

The studies are "a useful frame of reference" for studying that question, but not the final answer, he said (Fox News, 2012)

Title: Bird Flu Paper Is Published After Debate
Date: June 21, 2012
Source:
New York Times

Abstract: The more controversial of two papers describing how the lethal H5N1 
bird flu could be made easier to spread was published Thursday, six months after a scientific advisory board suggested that the papers’ most potentially dangerous data be censored.

The 
paper, by scientists at Erasmus Medical Center in the Netherlands, identified five mutations apparently necessary to make the bird flu virus spread easily among ferrets, which catch the same flus that humans do.

Only about 600 humans are known to have caught H5N1 in the last decade as it circulated in poultry and wild birds, mostly in Asia and Egypt, but more than half died of it.

The paper’s publication, in the journal Science, ended an acrimonious debate over whether such results should ever be released. Critics said they could help a rogue scientist create a superweapon. Proponents said the world needed to identify dangerous mutations so countermeasures could be designed.

“There is always a risk,” Dr. Anthony S. Fauci, the director of the National Institute for Allergy and Infectious Diseases, said in a telephone news conference held by Science. “But I believe the benefits are greater than the risks.”

Two of the five mutations are already common in the H5N1 virus in the wild, said Ron A. M. Fouchier, the paper’s lead author. One has been found in H5N1 only once. The remaining two have never been found in wild H5N1, but occurred in the H2 and H3 flus that caused the 1957 Asian flu pandemic and the 1968 Hong Kong flu.

The Dutch team artificially introduced three mutations. The last two occurred as the virus was “passaged” through 10 generations of ferrets by using nasal washes from one to infect the next.

Four changes were in the hemagglutinin “spike” that attaches the virus to cells. The last was in the PB2 protein.

As the virus became more contagious, it lost lethality. It did not kill the ferrets that caught it through airborne transmission, but it did kill when high doses were squirted into the animals’ nostrils.

Dr. Fouchier’s work proved that H5N1 need not mix with a more contagious virus to become more contagious.

By contrast, the lead author of the other bird flu paper, Dr. Yoshihiro Kawaoka, of the University of Wisconsin-Madison, took the H5N1 spike gene and grafted it onto the 2009 H1N1 swine flu. One four-mutation strain of the mongrel virus he produced infected ferrets that breathed in droplets, but did not kill any.

The controversy erupted in December when the National Science Advisory Board for Biosecurity asked that details be removed before the papers were published. On March 30, it reversed itselfafter a similar panel convened by the World Health Organization recommended publication without censorship.

Dr. Kawaoka’s work was published by the journal Nature last month.

Dr. Fouchier had to delay until the Dutch government gave him permission, on April 27.

Some of the early alarm was fed by Dr. Fouchier speaking at conferences and giving interviewslast fall in which he boasted that he had “done something really, really stupid” and had “mutated the hell out of H5N1” to create something that was “very, very bad news.” He said his team had created “probably one of the most dangerous viruses you can make.”

After the controversy erupted, he claimed the news media had overblown the danger.

Science magazine on Thursday published seven other articles about H5N1. One, by a team at Cambridge, concluded that it was not possible to accurately calculate the likelihood of all five mutations occurring in nature.

Up to three in a single human is “a possibility,” said Derek J. Smith, the lead author. “Five mutations is pretty difficult, but we don’t yet know how difficult it is,” Dr. Smith said.

Having H5N1 still circulating in birds is like “living on an active fault line,” he said. But asking whether a five-mutation strain could evolve in human hosts, he said, was like asking if it could ever snow in the Sahara — unlikely, but not inconceivable.

Presumably, if an outbreak with several of the most dangerous mutations were spotted, the world would move quickly to try to eradicate it with vaccines and quarantine; whether it would work is an unanswered question.

An important result of the controversy, Dr. Fauci said, is that the United States is now drafting new guidelines for dangerous research.

For the moment, most researchers are honoring a voluntary moratorium on this line of flu research.

Asked if a rogue researcher could now try to duplicate Dr. Fouchier’s work, Dr. Fauci said it was possible. But he argued that open discussion was still better than restriction to a few government-cleared flu researchers, because experts in unrelated fields, like Xray crystallography or viral epidemiology, might take interest and eventually make important contributions, he said.

“Being in the free and open literature makes it easier to get a lot of the good guys involved than the risk of getting the rare bad guy involved,” he said.

Dr. Fouchier said that many papers are published about pathogens more dangerous than flu.

Also, many scientists have said that the two papers have been so widely discussed that experts knew every detail anyway (New York Times, 2012)

Title: Paper On Altering Bird Flu To Be Published Despite Concerns
Date: June 22, 2012
Source:
USA Today

Abstract: Six months of scientific tug-of-war ended Thursday with the publication of a paper detailing how researchers took a deadly strain of bird flu and made it even more dangerous by creating a form that could be passed by a sneeze.

The work, involving the H5N1, or bird flu, virus initially caused a U.S. biosecurity committee to advise for the first time against publishing such research out of fear that terrorists could use the information to create a bioterror weapon.

The recommendation drew protests from other scientists and health officials who said describing the work could help other scientists and countries learn how to counter such microbes.

The debate ends in this week's edition of the journalScience, where work describing the research appears along with six comment pieces and two news articles about the findings and how scientists should deal with them.

The publication of the research will make the world safer by stimulating "scientists and policymakers to focus on preparing defenses," says Bruce Alberts, editor in chief of the journal.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Md., defended the publication. Each year, seasonal flu kills 250,000 to 500,000 people worldwide, and when new variants arise pandemic flu can kill millions. Making the research available in the scientific literature makes it easier to get the good guys involved, outweighing "the risk of getting the rare bad guy involved," Fauci said.

The controversial paper describes how the researchers in the Netherlands took three flu virus mutations from strains that caused worldwide pandemics in 1918, 1957 and 1968 and put it into an H5N1 bird flu virus. They then infected ferrets with it. Ferrets are used in flu research because they respond much as humans do — and they sneeze, which makes them the perfect animal model for detecting transmission. Despite the mutations, the flu still didn't easily spread between the animals via the air.

Next, they took nose swabs from one infected ferret and daubed them on another and then from the second to a third. After 10 passages between ferrets the virus "had acquired the ability to transmit via aerosol or respiratory droplets between ferrets," says Ron Fouchier, professor of molecular virology in the Department of Virology at the Erasmus Medical Center in the Netherlands and senior author of the paper. He believes as few as five mutations might be sufficient to make the H5N1 virus airborne.

Until now, bird flu passing from infected birds to humans was limited largely to people — typically farm workers — who worked closely with the birds. Bird flu almost never passes from person to person, so creation of a strain transmissible between mammals raised concerns should it escape the lab.

David Nabarro, a World Health Organization expert, estimated that such a pandemic could kill 20 million to 150 million people worldwide.

The most important thing the paper does is to underscore that a H5N1 pandemic is possible because the virus can become easily transmissible between mammals and presumably humans, which some had argued couldn't happen, says Eric Toner with the Center for Biosecurity at the University of Pittsburgh Medical Center.

The crucial issue now is to find out whether the "risk is 1 in 1,000 or whether it's 1 in 100 million," says Derek Smith, professor of infectious disease informatics at the University of Cambridge in the United Kingdom.

Others disagree about the paper's publication.

"I think it was really important work that should be done, but I think it should have limited distribution," says Michael Osterholm, director of the Center of Excellence for Influenza Research and Surveillance at the University of Minnesota. He believes the research broke what was very likely a "natural barrier" limiting transmission between mammals, and giving labs worldwide the knowledge of how to replicate that worries him.

The issue is far from over, he says. "There are many more papers that are on their way that will enable the rest of the world to do this work in a more comprehensive and easier way and I think we're ill prepared to deal with this."

Toner believes the paper should have been published, but thinks it underscores how unprepared the world is to catch a major flu pandemic early.

Since the research was first made public, the U.S. government has created a process for federal agencies to determine whether life-science research is potentially harmful, and to require that risk-mitigation plans be created when necessary.

Also, in response to the furor, the world's top influenza laboratories decided to institute a self-imposed moratorium on work that attempts to make the H5N1 virus more transmissible or dangerous. A meeting will be held in New York in July that will discuss whether the ban should be lifted, says Fauci (USA Today, 2012).

Title: Controversial Dutch H5N1 Study Published
Date: June 25, 2012
Source:
BioPrepWatch

Abstract: The second of two controversial H5N1 avian influenza studies was recently published in full after months of debate over its contents.

The study, which appears in the journal Science, details how a team of Dutch researchers created a strain of H5N1 avian influenza that is transmissible in ferrets and could spread through coughs and sneezes, according to ScienceNews.org.

The research suggests that only a few mutations could turn the virus into one that readily infects humans.

A U.S. government advisory board had originally asked the publishers of Science to redact the study because they feared it could be used to create a biological weapon. They also asked that a similar study conducted by U.S. and Japanese researchers be censored by the journal Nature.

The decision aroused heated sentiment in the scientific community surrounding the notion of censorship for the sake of security.

The panel then reversed its decision in March after reading revisions of the papers and conducting consultations with the researchers.

Vincent Racaniello, a virologist at Columbia University, has read both versions of the Dutch study and believes the controversy stems from a possible misinterpretation of the results.

“The data are the same, but the way it is explained is very different,” Racaniello said, ScienceNews.org reports. “Everything is explained and put in context” (BioPrepWatch, 2012).

Title:
Second Controversial H5N1 Study Published
Date: June 25, 2012
Source:
BioPrepWatch

Abstract: The second of two H5N1 transmissibility studies was published on Thursday in the journal Science, ending a waiting period and raising questions over how future dual-use research of concern and voluntary moratoriums will be handled.

The study was conducted by Ron Fouchier and his colleagues at the Erasmus Medical Center in the Netherlands. The first study, which was published last month in Nature, was conducted by Yoshihiro Kawaoka and his colleagues at the University of Wisconsin.

Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases, answered questions related to dual-use research and voluntary moratoriums on Wednesday during a press conference, CIDRAP News reports.

Fauci said that the U.S. government has learned critical lessons about dealing with DURC that led to the creation of federal agency guidelines that were published on March 29. The government is currently in the process of developing additional guidelines for biosafety commissions at research institutions to evaluate DURC.

In addressing the voluntary moratorium on DURC researchers agreed to in January, Fauci said that researchers are struggling with putting together criteria for the next phases of DURC research.

“I can’t tell you when it’s going to be voluntarily lifted, but we are working very hard right now to get a process in place where we could have some broad general criteria of the kinds of experiments that could be done,” Fauci said, according to CIDRAP News.

Fauci, along with Francis Collins, the director of the National Institutes of Health, co-wrote commentary to go along with the published study in Science. The authors wrote that communication must be made more effective between researchers in the government to avoid such conflicts in the future.

“The ultimate goal of the new US government-wide DURC policy is to ensure that the conduct and communication of research in this area remain transparent and open and that the risk/benefit balance of such research clearly tips toward benefiting society,” Fauci and Collins said, according to CIDRAP News (BioPrepWatch, 2012).

Title: Experts Condemn Plans To Lift Ban On Research Into Deadly H5N1 Birdflu Virus
Date: July 27, 2012
Source:
Independent

Abstract: Plans to lift a voluntary ban on research into the deadly H5N1 birdflu virus have been denounced by leading scientists who are appalled that the work has already led to flu strains that are potentially infectious between humans.

Flu researchers announced the moratorium last January after growing concerns about two experiments funded by the US Government where scientists deliberately mutated H5N1 birdflu to see whether it could be transmitted between ferrets, a standard animal substitute for flu in humans.

The moratorium on deliberately creating highly infectious strains of H5N1 was supposed to last 60 days but has continued for six months.

This weekend, influenza scientists will meet in New York in the hope of lifting the ban and allowing the work to continue.

However, leading experts contacted by The Independent said that lifting the moratorium would be wrong given that a highly-transmissible form of H5N1 birdflu - which is known to be extremely lethal to humans - could escape from a research laboratory to cause a deadly flu pandemic.

“The moratorium should be continued until a broader, dispassionate, international discussion can be held to carefully consider the risks and benefits,” said David Relman, professor of infectious diseases at Stanford University in California.

“The consequences of misuse or accidental release are potentially catastrophic on the global human and animal populations. Scientists have a deep moral and ethical responsibility to back off...it should not be decided by a group of flu researchers,” said Dr Relman, who also sits on the US National Science Advisory Board for Biosecurity.

The meeting in New York is being organised by the US National Institute of Allergy and Infectious Diseases whose director, Tony Fauci, has gone on record as saying that he would like to “expedite as quickly as possible the lifting of the moratorium”.

The institute is part of the huge US National Institutes of Health (NIH) which funded the two research projects into highly transmissible H5N1 virus. One was led by Ron Fouchier of the Erasmus University Medical Centre in Rotterdam, the other by Yoshihiro Kawaoka of the University of Wisconsin-Madison.

Richard Roberts, a Nobel prize-winning molecular biologist and expert in genetic engineering, said the moratorium should continue and that many experts are privately appalled that there are plans to lift it but are afraid of speaking out over fears that it might affect their funding from the NIH.

“It’s a big mistake at this point. The flu community is behaving as if they are the only show in town. I think for them to be allowed to create the most dangerous virus around is sheer lunacy,” said Dr Roberts, who although born in Britain works for a biotech company in New England.

“I’m not so much worried about terrorism but I am worried about an accidental escape from a laboratory. If it’s as dangerous as they believe, it could kill half the world’s population,” he said.

The H5N1 strain of avian influenza has caused the deaths of millions of birds and has decimated the poultry industry but so far it is known to have infected only about 600 people because it cannot be easily transmitted from one person to the next via coughs and sneezes.

However, it has kill six out of ten people it has known to have infected, making it far more lethal for instance than the 1918 strain of flu, even though it killed around 50 million people, about 2 per cent of the estimated number it actually infected.

Stanley Plotkin, a world authority on vaccines at the University of Pennsylvania, has written to Dr Fauci urging him to continue the moratorium. He said that creating a strain of H5N1 virus that is airborne transmissible would be like creating anthrax bacteria that could be easily spread from one person to another.

“History is full of incidents of escape of microorganisms from laboratories, and scientists are not always good at risk evaluation,” Professor Plotkin said.

Paul Berg and Stanley Falkow, two veteran scientists at Stanford who helped to organise the Asilomar conference in 1975 where a moratorium on genetic engineering was agreed, have told The Independent that they too oppose lifting the existing ban on H5N1 research.

Professor Berg said that lifting the moratorium is “a bit ludicrous” given that there is no scientific rationale to support an end to the voluntary research ban.

“There should be a serious review and evaluation of the concerns that led to the moratorium and a scientifically rigorous analysis of why the concerns can be managed before the moratorium could be lifted,” Professor Berg said.

Professor Falkow said: “The moratorium is essential until such time as there is a dispassionate international meeting to address the issues brought to the fore by the H5N1 affair.”

The view of the experts...

Two veterans from the Asilomar conference of 1975, when a moratorium was imposed on recombinant DNA technology, comment on proposals to lift the moratorium on attempts to make highly infectious strains of H5N1 virus:

Paul Berg, Emeritus Professor of Biochemistry, Stanford University School of Medicine:

“Frankly, I don't know who and under what circumstances the moratorium was declared. But once having announced it as being in effect, having the same people declare it undone without some public and clear scientific rationale is a bit ludicrous.  

Ostensibly, the moratorium was called because it was perceived that continuing to modifying the H5N1 virus genome could result in serious consequences; what consequences? Does lifting the moratorium mean they now believe there cannot be any serious consequences?

On whose assessment will that decision be made? It seems to me that having raised a caution there has to be a process that either recommends continuing the moratorium, modifies it in a scientifically justifiable way or agrees to lifting the moratorium because the original concerns were unwarranted.  

In short, there should be a serious review and evaluation of the concerns that led to the moratorium and a scientifically rigorous analysis of why the concerns can be managed before the moratorium could be lifted. That analysis would logically examine the kind of experiments investigators are planning, what scientific value can be gained by those experiments, how the results will be communicated and very importantly how the products of those experiments (the novel strains being produced) will be monitored and contained to prevent inadvertent release.

The H5N1 debate and the recombinant DNA debate are eerily similar and it's possible that an international meeting of stakeholders, like the one at Asilomar which included representatives of the public could agree on a way to proceed.

Stanley Falkow, Professor Emeritus of Microbiology and Immunology and Medicine, Stanford University:

“I  agree that the moratorium ought to be continued. My reasoning is that the moratorium is essential until such time as there is a dispassionate international meeting to address the issues brought to the fore by the H5N1 ‘affair’.  In my judgment there has been a lack of  leadership by the scientific community in dealing with this issue. The majority of statements from scientific leaders recently were often self-serving remarks and communications to journals from either biased virologists or those promoting doom and gloom.

What was needed was a plan for a way forward based on the premise that H5N1 was simply an acute exacerbation of a long smouldering problem that was diagnosed in the Fink report a decade ago  but still not treated appropriately for over a decade.

In contrast, I believe the behaviour of the scientists in the face of the recombinant DNA discovery in terms of their initiative and responsibility was admirable  and this kind of leadership  has been notably missing now. Of course, that was over 35 years ago and while there are certainly parallels between the implications for public health and society from the discovery of recombinant DNA technology and similar implications for dual use research, it is a different time and a different world. However, the social responsibility of a scientist remains the same regardless of the time” (Independent, 2012)

Title: Experts: Lifting H5N1 Research Ban Could Be Dangerous
Date: August 1, 2012
Source:
BioPrepWatch

Abstract: Leading scientists have denounced recent plans to lift the voluntary ban on H5N1 bird flu research for fear of releasing a highly transmissible strain into the environment.

The voluntary ban was the result of two controversial studies funded by the U.S. National Institutes of Health. The studies were led by Yoshihiro Kawaoka of the University of Wisconsin – Madison and Ron Fouchier of the Erasmus Medical Center in Rotterdam. The moratorium was instituted in January, the Independent reports.

Stanley Plotkin, an authority on vaccines at the University of Pennsylvania, has urged the U.S. National Institute of Allergy and Infectious Diseases to continue the voluntary ban on H5N1 research. Plotkin said that creating a more transmissible H5N1 strain would be like creating a more human-transmissible anthrax bacteria.

“History is full of incidents of escape of microorganisms from laboratories, and scientists are not always good at risk evaluation,” Plotkin said, according to the Independent.

Stanley Falkow and Paul Berg, two Stanford scientists, also oppose removing the ban on research into the H5N1 virus.

“Frankly, I don’t know who and under what circumstances the moratorium was declared,” Berg said, according to the Independent. “But once having announced it as being in effect, having the same people declare it undone without some public and clear scientific rationale is a bit ludicrous.”

Falkow said that scientists must exert social responsibility when considering a decision that could potentially end in disaster.

“I agree that the moratorium ought to be continued,” Falkow said, according to the Independent. “My reasoning is that the moratorium is essential until such time as there is a dispassionate international meeting to address the issues brought to the fore by the H5N1 ‘affair’. In my judgment there has been a lack of leadership by the scientific community in dealing with this issue. The majority of statements from scientific leaders recently were often self-serving remarks and communications to journals from either biased virologists or those promoting doom and gloom” (BioPrepWatch, 2012).


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