January 6, 2012

 

 

A World Health Organisation (WHO) official suggests that bird flu studies that are opposing influenza researchers and scientific journals on bio security experts raise complex issues and should be unframed in simplistic terms by proponents or opponents of their publication.

 

While it's tempting to boil the arguments down to a single issue - the evils of censorship, the sanctity of open science, the dangers of bioterrorism - to do so ignores the many difficult questions that the scientific, public health and security worlds need to work through to forge a path forward, Dr Keiji Fukuda, an influenza expert and the WHO's assistant director-general for health security and environment said in an interview. Fukuda was commenting on the roiling controversy surrounding two unpublished studies about the H5N1 flu virus.

 

The studies reportedly detail how researchers in the Netherlands and the US pushed H5N1 avian influenza viruses to evolve to the point where they became easily transmissible among ferrets. Ferrets are considered the best animal model for predicting how a flu virus will act in people.

 

The studies, in the publishing pipelines of the journals Nature and Science, drew the concern of an expert group that advises the US on bio security issues and so-called dual-use research - legitimate scientific work that could be used for nefarious purposes.

 

The National Science Advisory Board on Biosecurity urged the US government - which followed the advice - to ask the journals not to publish the guts of the studies, suggesting they are in effect recipes for how to turn H5N1 viruses into a potentially potent bioterrorism weapon.

 

Now a variety of parties, including the journals and the leading US biomedical research agencies, are trying to figure out how to set up a system that allows the findings to be published in abbreviated form, with the proviso that more detail will be provided on a need-to-know basis to other researchers, public health agencies and potentially others.

 

The WHO recently weighed in on the heated debate that has ensued, trying, in Fukuda's words, to "bring some balance to the discussion." The move in part was motivated by concern that the controversy - and any impact it may have on H5N1 science - might ground the WHO's efforts to get up and running a critical compromise called the Pandemic Influenza Preparedness Framework that was devised over four painful years of negotiations.

 

The system is designed to ensure flu viruses with pandemic potential are filtered into international surveillance networks and on to researchers who can study them. In exchange, countries will reap benefits that might include access to pandemic vaccine or funding for surveillance activities provided by pharmaceutical companies that use the viruses to make vaccines.

 

The framework was approved last May at the World Health Assembly - the WHO's governing council - and is in the early implementation stages.

 

"It's a very delicate period," Fukuda said. "It's a really quite important framework in our viewpoint and something which, if it doesn't get implemented, it's not going to be easy - and it may be impossible - to get back there again."

 

The WHO is also worried, though, that a tendency to see the controversy through a single frame - censorship versus bioterrorism, for example - is failing to highlight the myriad pressing questions that now need answering.

 

Now that these viruses exist, what will be done with them? Can they be transported so that other researchers can work with them? If further work is going to be done on them, where will that work be done? Will the methods used be the safest possible?

 

Fukuda noted it's being argued that the modified viruses should be studied in animals to see if antiviral drugs and prototype H5N1 vaccines protect against severe disease or infection.

 

"In principle that sounds good, but where are you going to do it? How are you going to do it?" he asked.

 

Other questions that should be considered now - not after results have been arrived at - include what will be done with the information further studies generate? If it is also deemed too sensitive from a security perspective, how will it be handled?

 

One question that is being raised relates to the bio security and bio safety designations of the facilities in which work on these viruses is done. Some parties are questioning whether future work on the viruses should be limited to labs with the highest bio security protections, Level four.

 

H5N1 work is typically done in Level three-plus labs - an intermediate step between Level three and the highly expensive and cumbersome Level four, used for the most dangerous pathogens such as the Ebola virus. The Dutch and American research teams did their work under three-plus conditions, but neither has a Level four lab.