NIH endorses recommendation to publish H5N1 studies

Apr 20, 2012 (CIDRAP News) – The US National Institutes of Health (NIH) has endorsed the recommendations of its biosecurity advisory committee to publish the full versions of two studies describing lab-modified, mammalian-transmissible H5N1 flu viruses, NIH officials announced today.

The step signals an end to formal US government opposition to full publication of the two papers authored by Yoshiro Kawaoka, DVM, of the University of Wisconsin and Ron Fouchier, PhD, of Erasmus Medical Center in the Netherlands. But the Dutch government has been using export-control laws to stop Fouchier from submitting his revised manuscript to Science. Kawaoka's study is expected to be published in Nature.

In a statement today, NIH Director Francis Collins, MD, PhD, announced his endorsement of the recent recommendations by the National Science Advisory Board for Biosecurity (NSABB) that the two studies be published in full. The NSABB made the recommendations on Mar 30, reversing its December recommendation that the journals should withhold details of the studies, out of concern that malefactors or irresponsible scientists might misuse them and endanger public health.

"The HHS Secretary [Health and Human Services Secretary Kathleen Sebelius] and I concur with the NSABB’s recommendation that the information in the two manuscripts should be communicated fully and we have conveyed our concurrence to the journals considering publication of the manuscripts," Collins said. "This information has clear value to national and international public health preparedness efforts and must be shared with those who are poised to realize the benefits of this research.

"The Secretary’s decision takes account of relevant US law, international obligations, and a rigorous analysis of the benefits and risks of publication," he said. "The work in the Netherlands by Ron Fouchier is subject also to laws and regulations of the Netherlands, and the Dutch government is conducting its own review of Dr. Fouchier’s work. We respect that process and value the dialogue we have with Dutch authorities toward our common goals of encouraging scientific inquiry, advancing global health, and protecting the safety and security of our populations and the wider global community."

Collins's statement noted that the NSABB met to reconsider the two manuscripts after the authors revised them to clarify some points. The board voted unanimously to endorse publication of Kawaoka's full manuscript, but the members split 12-6 in favor of full publication of Fouchier's paper.

Collins stated, "The recommendation to communicate the research was based on the observation that the information in the revised manuscripts has direct applicability to ongoing and future influenza surveillance efforts and does not appear to enable direct misuse of the research in ways that would endanger public health or national security."

But the fate of Fouchier's manuscript remains uncertain. He is scheduled to meet with Dutch government officials, journal editors, and international health officials Apr 23 and 24 to discuss the risks and benefits of publishing his research.

Dutch officials have said Fouchier must apply for an export permit to publish his paper in Science and that the government plans to decide after next week's meeting whether to grant an export license. But earlier this week Fouchier said he would submit his revised manuscript to Science without applying for an export permit.

In other developments today, the NIH released a short statement in response to criticism from one NSABB member about the handling of the Mar 29-30 meeting at which the board voted to recommend publication of the two research reports.

In a letter to the NIH and NSABB that was leaked last week, Michael T. Osterholm, PhD, MPH, asserted that NIH officials fashioned a biased agenda and set of speakers to induce the board to reverse its earlier recommendation. Osterholm is director of the University of Minnesota Center for Infectious Disease Research and Policy, publisher of CIDRAP News.

Osterholm, who said he spoke only for himself, charged that the board "kicked the can down the road" regarding the science policy issues at stake. He was one of the six members who voted against publishing the Fouchier paper.

In a statement released to CIDRAP News today, the NIH said, "The NSABB agenda was developed through a careful deliberation with the aim of having the most scientifically rigorous review of the revised manuscripts and new data, discussion by influenza public health experts about the implications of the data for human health, and an in-depth briefing on the latest security information relevant to influenza research."

See also:

Apr 20 statement by Francis Collins

Apr 17 CIDRAP News story "Fouchier plans to flout Dutch export law, publish H5N1 study"

Apr 16 CIDRAP News story "NSABB wants clarifications in Fouchier's H5N1 manuscript"

Apr 13 CIDRAP News story "NSABB member says officials stacked deck for board's H5N1 decision"

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