WHO H5N1 study group extends moratorium, calls for full publication

Feb 17, 2012 (CIDRAP News) – Flu and public health experts meeting at the World Health Organization (WHO) on issues surrounding two controversial H5N1 transmission studies today agreed on a plan to extend a voluntary research moratorium but publish the full results at a later date.

The temporary moratorium applies to new lab-modified H5N1 viruses, though the group agreed the research on naturally occurring H5N1 viruses must continue to protect public health.

The 2-day meeting of 22 technical experts included the two researchers who led the studies, Ron Fouchier, PhD, and Yoshihiro Kawaoka, DVM, PhD, and representatives from the US government institute that funded the studies, along with a member of the National Science Advisory Board for Biosecurity (NSABB).

The NSABB in December recommended that key details of the studies be redacted. Editors from Science and Nature, the two journals slated to publish the studies, also participated in the meeting, along with several international flu experts.

At a press briefing at the end of the meeting today, Keiji Fukuda, MD, the WHO's assistant director-general of health security and environment, said the meeting is only the first step in addressing the issues and was designed to consider the two most urgent topics.

Fukuda said one of the main rationales behind the pauses in publication and research is to allow research groups and organizations to explain the nature and importance of the work to the public. He said the time-out will also allow experts to address safety and biosecurity concerns about the research.

Fukuda added that the lab-modified strains will stay at the two labs, one at Erasmus University in the Netherlands and the other at the University of Wisconsin at Madison. Safety standards at the two labs are high, but reexamining safety issues is a prudent step to take, Fukuda said.

Fukuda said that although the 2 days of discussions were intense and wide ranging, the group reached consensus on all of the major points except for the decision to publish in full, which was not supported by NSABB chair Paul Keim, PhD, and Anthony Fauci, MD, director of the US National Institute of Allergy and Infectious Diseases.

He said the issues that have been raised reinforce the importance of H5N1 risks. "On the basis of that, they agreed strongly that research needs to continue. New knowledge is critical for filling in some of the important gaps in knowledge."

During discussions about the possibility of redacting the studies, a measure proposed by the NSABB, experts identified a large number of complex issues and unanimously agreed that putting such a process in place quickly was not possible, Fukuda said, adding that the group felt that full disclosure was preferable.

Postponing the publications, "shows how strongly concerned many individuals are about safety," he said.

Fukuda said in the wake of the NSABB recommendations, experts have had several weeks to consider what it would take to redact the papers, which he said would be very difficult. "These discussions here are very much of the thoughts of the NSABB. These are important issues, and we ought to move along carefully," he said.

Fukuda said the next steps are for the WHO and other organizations to increase public awareness about the work and for scientific groups to examine the biosecurity issues in more detail. He said the group didn't set any specific time periods for pauses in research and publication. "Hopefully, this all can be done in a matter of months," Fukuda said.

Fukuda reiterated that the meeting was just the first step in addressing the issues and that the discussion raised many broad issues about balancing the concerns and benefits of dual-use research, not only for viruses, but also for other health threats. The discussions also identified the need to address the complex ethical dimensions of dual-use research, he said.

During a press conference today, Bruce Alberts, PhD, editor of Science, said his interpretation of the WHO group's consensus is that Science and Nature should wait for further information from the WHO and other authorities about when the full manuscripts can be published. Originally, the papers had been on track for publication in the middle of March, he said.

Alberts was speaking at the annual meeting of the American Association for the Advancement of Science (AAAS) in Vancouver.

Though he said the request to delay publication is unusual, Alberts said he understood the need to address public perceptions. "I can certainly understand the reason for doing so from a public perception [standpoint] because there's been a great scare among the public whipped up in the last few months, and that needs to be dealt with."

In the meantime, he encouraged officials to establish a mechanism for sharing details of sensitive research going forward. "I hope they can work out a mechanism for future use. It's very important that the next time this kind of thing happens we have a mechanism already established."

Peter Sandman, PhD, a New Jersey-based risk communications consultant, told CIDRAP News that two factors would seem to weight the group toward opposing restrictions on research: the heavy involvement of scientists and the WHO's interest in protecting its fragile virus-sharing agreement.

He said the publication recommendation also appears to be a compromise, "apparently in the hope that complete publication might be feasible after the public's concerns are addressed."

The developments raise the question of how the groups intend to address the public's concerns, Sandman said. "Even a respectful dialogue will help, but not ensure, a consensus that favors unredacted publication and unfettered research on a virus that could launch a catastrophic pandemic," he added. "Still, it could lead at to a compromise, and to a shared understanding of what's at stake."

Sandman said he fears that the group will try to "educate" the public out of their concerns, a strategy risk communicators call "decide, announce, defend."

"It [the strategy] is thoroughly discredited, because it doesn't work," he said. "It certainly doesn't work when serious risks are involved.  'How safe is safe enough?' is a values question for society, not a science question for experts who have a horse in the race."

In watching the debate unfold, Sandman said both sides seem to be marshalling ammunition rather than assessing evidence. He said he believes that scientists representing the public's concerns as "perceptions" or "fears" are casting those concerns as unjustified, which he said could backfire and provoke stricter regulation of science.

The discussions of the lab-modified H5N1 strains have neglected consideration of what the new findings tell the world about the risk of a naturally occurring H5N1 pandemic, Sandman said.

"Maybe, just maybe, the Fouchier and Kawaoka papers offered a teachable moment, a chance to overcome accumulated skepticism and alert people—or re-alert people—to the risk of an H5N1 pandemic.

"But that teachable moment got hijacked in large measure by a sideshow discussion of the pros and cons of unfettered research and publication," he said.

Editorial director Jim Wappes contributed to this article.

See also:

Feb 17 WHO press release

Feb 17 WHO press briefing audiocast

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