NSABB wants clarifications in Fouchier's H5N1 manuscript

Apr 16, 2012 (CIDRAP News) – The US National Science Advisory Board for Biosecurity (NSABB) says in a new report that one of two controversial H5N1 avian flu studies needs some clarifications before publication and that some additional information the board heard from the lead author should not be included in the paper.

Over the weekend the NSABB released a report offering new details on its meeting held Mar 29 and 30, when the board reversed its earlier recommendation against full publication of H5N1 studies led by Ron Fouchier, PhD, of Erasmus Medical Center in the Netherlands and Yoshihiro Kawaoka, DVM, PhD, of the University of Wisconsin. The studies describe lab-modified H5N1 viruses that can spread in ferrets by the airborne route.

The board in December had recommended withholding key details of the two studies out of concern that someone could use the data to create and unleash a highly dangerous virus. After the authors provided additional data on their findings, the board met to reconsider the recommendation.

At the meeting, the board unanimously endorsed publication of Kawaoka's revised manuscript in full. On Fouchier's manuscript, the panel approved publication of the "data, methods, and conclusions" on a 12-6 vote, but said the manuscript needed some revisions, according to the new report.

"The Board identified a number of scientific clarifications that should be made prior to publication of the manuscript," the report says, without describing them.

The recommendation continues, "Importantly, the Board also noted that additional information that would enable the construction of an H5N1 virus that is both highly pathogenic and transmissible between mammals through the air should not be included in the manuscript. Such information could conceivably be directly misused to threaten public health or national security and additional considerations regarding communication would be necessary."

This sounded like a reference to the same data that was mentioned by NSABB member Michael T. Osterholm, PhD, MPH, last week in a leaked letter in which he charged that US government officials picked the meeting agenda and speakers with the aim of getting the board to reverse its original recommendations. Osterholm was one of the six members who voted against full publication of Fouchier's findings.

In the letter, Osterholm wrote, "We heard from Dr. Fouchier that he has already identified an additional mutation (not included in his current manuscript) that results in ferret-to-ferret transmission (mammalian transmission) without the need for repeated passage of the virus in ferrets. This work, which may have been supported by NIH funds, surely must be considered as a candidate for the next manuscript to be before the NSABB for review."

Osterholm declined to comment today on whether he was referring to the same information as cited in the NSABB recommendation. His letter asserted that the NSABB recommendations "just kicked the can down the road to the next manuscript."

Limited sharing mechanism still sought
In other recommendations detailed in the new report, the NSABB said the US government "should expeditiously develop a mechanism to provide controlled access to sensitive scientific information."

The board's earlier recommendation had said such a mechanism should be used to convey the unpublished details of the two studies to responsible scientists on a need-to-know basis, but deliberations by experts convened by the World Health Organization in February led to a conclusion that it wasn't possible to devise such a mechanism quickly.

US and Dutch regulations restricting the exporting of sensitive information have been cited as one of the obstacles to such a system.

The other recommendation in the new report says the US government "should continue to develop national, and participate in the development of international, policies for the oversight and communication of dual use research of concern."

The NSABB makes its recommendations to the National Institutes of Health (NIH), part of the US Department of Health and Human Services, which must decide whether to forward them to the two journals expecting to publish the papers—Science and Nature. HHS officials have not yet made a decision about the recommendations, NIH spokeswoman Renate Myles told CIDRAP News today.

In an Apr 14 statement, NIH Director Francis Collins, MD, PhD, said, "A final recommendation of these two revised manuscripts regarding the transmissibility of the H5N1 avian flu virus in ferrets will be made by the HHS Secretary and brought to the broader US government."

More on the rationale
Also in the new report, the NSABB offered more details on the rationale for reversing its earlier recommendation and on the thinking of those who voted against full publication of Fouchier's study.

The reasons the board cited for endorsing publication include:

  • The mutations described in the studies "do not appear to result in H5N1 viruses that are both highly pathogenic and transmissible between ferrets through the air."
  • The data "may benefit public health and surveillance efforts."
  • Not publishing the information could endanger global pandemic influenza preparedness efforts.
  • The studies were conducted under "rigorous biosafety conditions."

Those who opposed full publication of Fouchier's data, according to the report, concluded that:

  • The mutations described in the study "appear to result in modified H5N1 viruses that are transmissible between ferrets by respiratory route" and that seem to be as pathogenic as the parental H5N1 strains.
  • "While the data in the two manuscripts may benefit public health and surveillance efforts, these data may not be directly relevant or immediately helpful to the current public health or surveillance infrastructure."

See also:

New NSABB report

Apr 14 Francis Collins statement

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

Mar 30 CIDRAP News story "NSABB reverses recommendation on H5N1 studies"

NSABB statement released immediately after Mar 29-30 meeting

Apr 10 CIDRAP News story on export control issue

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