H5N1 virus (avian flu) generated in lab, now WHO vs security on disclosure

By Anna Mehler Paperny, Globe and Mail, February 22, 2012
When two groups of scientists on either side of the Atlantic engineered a highly contagious strain of avian flu, their findings were variously hailed as brilliant, groundbreaking – and reckless.

Late last year, researchers in the United States and the Netherlands announced they'd manipulated the H5N1 virus so it could be spread between mammals and through the air. It’s a global first for a virulent virus. And if the dangerous, transmissible mutation were unleashed – by accident or through malice – it could have pandemic consequences.
At a special meeting in Geneva last week, the World Health Organization recommended that the sensitive research be published, igniting a tussle within the ranks of global leaders on science, health and security: At what point does potentially life-saving data become reckless bait for would-be bioterrorists?

The recommendation to publish flies in the face of pleas for self-censorship from a U.S. government watchdog, the National Science Advisory Board for Biosecurity. The board asked researchers to hold back on releasing crucial “how-to” portions of their work for fear the details would fall into the wrong hands and spark germ warfare on a global scale. Anyone who needs the information for legitimate research, the board reasoned, could make a special request for it.
Not good enough, the WHO committee decided. The new knowledge, every last bit of it, should be freely available. From a public-health perspective, the committee wrote in a statement, full disclosure is the best option.
That conclusion is sending shock waves through the global scientific, epidemiological and counter-terror communities.And it has particular resonance in Canada.

Save the world from pandemic
The scariest thing about infectious-disease research is that the most dangerous disease out there is the one you don’t know about, because it doesn’t exist yet.
Scientists developing new vaccines can barely keep pace with the rate at which virulent viruses morph into something just different enough to evade the latest cutting-edge treatment.
So it’s no surprise that microbiologists and immunology researchers want to get ahead of the game by trying to guess which way a virus will mutate next – and how it will behave once it shape-shifts.
From this perspective, details of the powerful avian flu created in labs at the University of Wisconsin and the Erasmus Medical Centre in Rotterdam are of maximum importance to people in the business of stalking viruses.
Details of a microscopic viral mutation can mean the difference between recognizing a lethal breed of disease and missing its significance altogether, says Gary Kobinger, a University of Manitoba microbiologist and head of vector design and immunotherapy at the National Microbiology Laboratory of the Public Health Agency of Canada.
If scientists on the lookout for new flu mutations find one whose fingerprint matches this one, they’ll respond very differently than they would without that knowledge, Dr. Kobinger says.
The Winnipeg site is home to Canada’s highest-security bio-safety laboratory, where Dr. Kobinger and his colleagues are researching new vaccines and testing virulent diseases. Knowing what human-transmissible H5N1 looks like would make a huge difference for those watching out for new natural mutations of the virus.
“It’s a very important public-health impact,” says Dr. Kobinger. But “we'd need to have the details. If we don't have the mutation, we're back to square one.”
Canada has a lot on the line in this field. Ottawa is spending hundreds of millions of dollars on experiments researching biological and chemical weaponry.
The military’s research and development arm, Defence Research and Development Canada, has its own biological defence program with an annual budget exceeding $8-million. Separate research into chemical, biological, radiological, nuclear and explosive technology has a multi-year budget of $175-million through the end of this year. Between 2002 and 2011 it undertook 152 research projects with a combined budget of $241-million.
These experiments range from developing new vaccines for the world’s most dangerous diseases to coming up with new ways to detect biological weapons and clean contaminated sites.

Meanwhile, the U.S. scientist behind the mutated flu virus has stepped into the fray to defend his work.
“Some people have argued that the risks of such studies – misuse and accidental release, for example – outweigh the benefits. I counter that H5N1 viruses circulating in nature already pose a threat,” University of Wisconsin researcher Yoshihiro Kawaoka wrote in an online commentary at Nature.com. “It would be irresponsible not to study the underlying mechanisms.”
(Dr. Kawaoka himself has been unavailable for interviews.)
Philip Campbell, the editor-in-chief of Nature, welcomed the WHO’s recommendation. “Discussions at the WHO meeting made it clear how ineffective redaction and restricted distribution would be for the Nature paper,” he said in a statement. “It also underlined how beneficial publication of the full paper could be. So that is how we intend to proceed.”
An editorial published Wednesday evening on Nature's website had a similar rationale: Unless there are additional, as-yet undisclosed biosecurity or biosafety risks, it reads, "it is Nature's view that the papers should ultimately be published in full."
It can be tough to argue in favour of secrecy in a world where disclosure is the norm and information is increasingly accessible. But as Peter Singer, director of the Sandra Rotman Centre at Toronto’s University Health Network, observes, “global health and bio-security go hand in hand. You can’t have one without the other – we need a balance.
Annihilation of the human species

The biosecurity community is flummoxed that anyone would dismiss expert pleas for secrecy surrounding a human-engineered virus that could be the most dangerous breed of flu on earth.
The spectre of a global pandemic spawned by germ warfare is less the stuff of science fiction and more a reality taken seriously by policy-makers, militaries and security experts worldwide.
For most people the quickest mental reference is the anthrax scare of 2001. But the potential for havoc in 2012 is much greater – and the barrier to accomplishing it much lower.
“Capabilities have been evolving remarkably quickly. … And with that comes the capability of either deliberately or unintentionally creating, in this case, a living product that’s of serious concern,” says David Relman, a Stanford University microbiology expert and a voting member of the U.S. National Science Advisory Board for Biosecurity, which recommended holding back key details of the experiments.
It’s called “dual-use” research –knowledge that has the potential to save lives, or end them.
A 2006 paper on globalization and biosecurity from the National Academies Press noted how quickly technology is changing the implications of previously innocuous research.
“As with all scientific revolutions,” the paper reads, “there is a potential dark side to the advancing power and global spread of these and other technologies. … Most experts believe it naive to think that the extraordinary growth in the life sciences and its associated technologies might not similarly be exploited for destructive purposes.”
As far as Dr. Relman is concerned, research as dangerous as these particular H5N1 flu experiments should not have been going on in the first place.
“You need to show how the work will lead to major, major benefits right away,” he said. “If they cannot show an immediate, tangible, real, scientifically supportable benefit, they shouldn’t have done it.”
Those who argue against even attempting such research note that the safest laboratories are far from foolproof. According to a 2009 report from the U.S. government accountability office, some of the country’s most secure labs reported 400 accidents in the preceding decade, caused by both human error and system failure.
(This particular experiment was done in a “bio-safety level 3” lab – the second-highest level of security that exists. The Public Health Agency of Canada stipulated this month that any Canadians wishing to tinker with a human-transmissible bird flu virus must keep it in a bio-safety level 4 lab. Now other countries are considering following suit.)

Lawrence Librach, director of the University of Toronto’s Centre for Bioethics, goes a step further: The scientists in question, well-intentioned as they might have been, abrogated their responsibilities, he contends.
“Although I respect freedom to speak and academic freedom, this is too risky and the scientists have to act responsibly. I do not believe they are acting responsibly.”
Others argue the research is valuable and should be done – but that its findings, and especially detailed instructions on how to replicate it, be kept under wraps.
“We don’t need every Tom, Dick and Harriet to know which mutations will cause an awful pandemic,” Dr. Singer said. “We do need the people developing flu vaccines and flu surveillance to know that.” Hence the proposal for selective release upon request.
Dr. Relman says he has “mixed feelings” about the WHO’s decision to ignore his board’s advice. But more crucially, he thinks they overstepped their turf.
“I don't think they really were in a position to offer that kind of recommendation,” he said. “I would hope that people who have larger decisions to make would turn to a broader representation of the various interested and relevant parties.”
What comes next

The precise fate of the pair of studies into the H5N1 virus is still uncertain.
While Nature magazine has made clear it agrees with, and hopes to follow, the WHO’s recommendation, there is as yet no timeline on publication. Future discussions are in the offing, but timing and scope are still vague.
In the meantime, international consternation has thrust the issue into the limelight. And that’s arguably a good thing.
“The whole notion of dual-use research … has been promoted in a very useful way: Many more people are aware that there is such an issue,” Dr. Relman said. “On the negative side, the tenor of the discussion has sometimes become very polarized and accusatory. And I think that’s unfortunate.”
At the very least, the kerfuffle should force scientists, security experts and policy-makers to come up with a better mechanism to figure out what happens next time.
“If this is leading to an environment where there’s oversight from different backgrounds … I think that’s very positive,” Dr. Kobinger said, adding that he’s optimistic this won’t cast a chill on bolder experimentation.
“At the end of the day we all want better treatment. We all want better drugs. There’s a lot of devastating chronic diseases we don’t have a solution for. The only way to tackle this problem would be research.”
Canada’s lab-safety edict earlier this month is just one example of the fire that has been lit under jurisdictions that simply hadn’t thought of dealing with a situation like this. And Dr. Singer is hopeful Canada will have a significant role to play on the global stage. “Canada can contribute a lot to resolving this in a balanced way,” he said.
Dr. Relman warns that this scenario is guaranteed to occur again.
“Examples like this will absolutely arise again. Possibly with increasing frequency.”
Here is a rivetting case in which the parameters of the research biologists, and the WHO in favour of disclosure and the security establishment's position of repressing the data need a full airing, in an arena where decisions made, and arguments proferred can be made available to the world community. We are all interested in the implications of this "dual-research science" because our lives are at stake, no matter which side of this debate is held to be stronger, in the long run.
So far, we do not have any body, designated by the world community, outside national boundaries, and with a body of laws and a stable of jurists, before whom these arguments can be put and from whom we can expect reasoned and balanced decisions, without either failure to hear all relevant arguments from all academic disciplines, or fear of being manipulated by one side or the other.
And with the pace of both terrorism and counter-terrorism, and the pace of the mututions of virulent bacteria, the world's clock is ticking, relatively quickly. So creating mechanisms for the appropriate airing of these conflicting interests which clearly cross national borders, time zones and eonomic conditions would seem, at least to this observer, an urgent item on the world's agenda.
Anyone heard a political leader talking about such mechanisms lately? The silence deafens.