Two separate teams of scientists trying to develop a vaccine for the H5N1 strain of bird flu have agreed to temporarily postpone their research because of growing concern that a highly-infectious version of the virus the researchers are working with could fall into the hands of terrorists or trigger a deadly pandemic.

The laboratory-altered strain the scientists are working with is a potent airborne variety of H5N1 that easily could spread among humans. The original H5N1 strain of avian influenza has killed 340 people worldwide since it was first detected in 2003.

Scientists at the University of Wisconsin in the United States and at Erasmus University Medical Center in the Netherlands say they are voluntarily halting their work for 60 days. They say the two months will give governments, international organizations and the scientific community time to determine whether the research can be conducted safely.

Biosecurity officials and health experts say that if the potent altered virus reached the general public, it potentially could cause a devastating pandemic. Some fear a worldwide epidemic of airborne bird flu could rival the 1918 Spanish flu outbreak that killed between 20 million and 40 million people in less than two years.

The U.S.-based journal, Science and the British journal, Nature, both published the researchers’ announcement on Friday.

The original H5N1 strain of avian influenza is not transmitted through the air, and it does not spread easily among humans. H5N1 usually only infects people that come into direct contact diseased birds.

In December, the journals, Science and Nature, reluctantly agreed to a U.S. government request not to publish key details of the H5N1 experiments because terrorists could use the information to make a biological weapon. It is not clear if or when studies will be published. Washington is funding the H5N1 research.

Most H5N1 deaths have occurred in East and Southeast Asia, including China, Cambodia and Vietnam.

Some information for this report was provided by AP, AFP and Reuters.

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WHO to lead talks on controversial H5N1 studies

Lisa Schnirring * Staff Writer

Jan 17, 2012 (CIDRAP News) – A World Health Organization (WHO) official said the agency will play a role in leading discussions on issues related to controversial H5N1 avian influenza transmission studies, as more experts called for a further global discussion of the issues.

Dr Keiji Fukuda, assistant director-general of health security and environment at the WHO, said the WHO will organize international talks to define the issues concerning the H5N1 studies and begin resolving them, the Canadian Press (CP) reported on Jan 15.

Two papers that describe mutant forms of H5N1 that were easily transmissible among ferrets have been submitted to journals, and the scientific and biosecurity communities have been at odds over whether the complete details should be published. The concern is that publication of the full papers could lead to the unleashing of a highly dangerous virus either through criminal activity or a lab accident.

Fukuda told the CP that the WHO is the right agency to ensure that discussions reflect balanced perspectives that take into account technical, scientific, public health, and political considerations. The WHO itself has voiced concern that H5N1 research like the two studies now at issue could threaten a new virus-sharing agreement that took effect in May 2011.

"It's genuinely a set of difficult and very important questions," Fukuda said.

One of the as-yet-unpublished H5N1 studies, by a team led by Dr. Ron Fouchier of Erasmus University in the Netherlands, was submitted to Science. The other, led by Dr. Yoshihiro Kawaoka of the University of Wisconsin and the University of Tokyo, was submitted to Nature.

The US government has asked the journals to omit key details, following a recommendation by its advisory panel, the National Science Advisory Board for Biosecurity (NSABB). The journals have said they might go along with the recommendation if a mechanism can be found to share the full details with responsible scientists.

Representatives from both research teams and several other experts weighed in on the issues in a series of short commentaries published Jan 15 in Nature. Some called for a more global discussion of the issues, and said the WHO is ideally positioned to play a key role.

In one of the commentaries, two researchers from the first group, Fouchier and his colleague Dr Albert Osterhaus, questioned how appropriate it is for one country—the United States—to dominate the discussions, since they have global public health significance.

The two said they were not questioning the NSABB's recommendation to remove key details from the two manuscripts, and that it's not clear if an international discussion would produce different recommendations. They also asserted that talks should include people from regions where H5N1 has infected humans.

"We don't know the worldwide opinion until a group of experts from all parts of the globe is formed. An issue this big should not be decided by one country, but by all of us," Fouchier and Osterhaus wrote.

Another commenter, Dr John Steinbruner, director of the Center for International and Security Studies at the University of Maryland, suggested that short- and long-term solutions are needed to handle issues related to current and future H5N1 transmission papers. "I believe the entire process must be regulated by a global health body, ideally the World Health Organization," he wrote, adding that a system for guiding research on H5N1 and other deadly pathogens could be modeled after the WHO committee that oversees smallpox virus research.

Steinbruner acknowledged that it could take some time to gain the participation of all countries, but in the short-term, the WHO or some other group should quickly establish an ad hoc committee to review who should have access to the full details of the H5N1 papers.

He also said the discussion should not be controlled by national security officials, who might vet scientists based on their nationality. H5N1 is primarily a public health matter, and some countries that are home to terrorists have experienced human deaths from the disease and are vulnerable in the event of an outbreak, he wrote.

Other experts argued that the risk of an accidental release could be higher than that of a natural pandemic or a bioterrorist attack. Dr Lynn Klotz, senior science fellow with the Center for Arms Control and Non-Proliferation in Washington, DC, and Dr Ed Sylvester, professor at Walter Cronkite School of Journalism at Arizona State University, calculated the likelihood of a lab escape involving a highly contagious form of H5N1.

Based on the number of escapes of the SARS (severe acute respiratory syndrome) virus and the number of labs that work with dangerous pathogens, they estimated a 34% probability of an escape in a single year. Within 4 years, the probability would rise to 80%, they wrote. In comparison, they said the interval between pandemics over the last century averaged 30 years. "We are creating a risk that is much greater than that posed by nature," Klotz and Sylvester wrote.

In other commentaries, experts emphasized the importance of viral-adaptation work, called for an increase in biosecurity requirements for research on highly transmissible strains of H5N1, and reiterated the need for a vaccine against the virus, even if all the lab samples are destroyed.

Michael T. Osterholm, PhD, MPH, a member of the NSABB and director of the University of Minnesota's Center for Infectious Disease Research and Policy, which publishes CIDRAP News, said the WHO's move to lead discussions on the H5N1 study issues is an important step forward. "We need global leadership, and this is the obvious institution for this to happen," he told CIDRAP News.

He said the view that the United States is dominating the discussions about the H5N1 papers is a misperception. The NSABB, an advisory group of the National Institutes of Health, raised concerns about the papers because the US government funded the studies, he said.

The committee has received ample input from experts throughout the flu community, he said, adding, "No one is suggesting that this is a US issue."





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