Insider: H5N1 studies publication vote biased, unbalanced

Osterholm wrote. “It represented a very ‘one-sided’ picture of the risk-benefit of the dissemination of the information in these manuscripts.”

He wrote that there was a bias toward finding a solution that was more about getting the government out of the current dilemma than about a careful risk-benefit analysis weighing science and policy considerations, but he prefaced that statement by saying he is not suggesting a sinister motive.

In that context, Osterholm revealed that Fouchier disclosed at the meeting that he has already identified another H5N1 mutation, not described in his current manuscript, that results in ferret-to-ferret transmission of the virus “without the need for repeated passaging 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,” he wrote. “What scientific and policy issues will differ with this ‘incrementally changed manuscript’ compared with the issues we just covered?”

Osterholm asserted that the meeting included no unbiased review of the current state of reverse genetics technology that might allow those without great expertise or resources to duplicate the experiments. The experts who addressed the issue had a conflict of interest because they are involved in the same type of research as Fouchier and Kawaoka are and will be affected by the board’s recommendations, he said.

He also wrote that the board did not hear from anyone involved in frontline surveillance and control efforts for H5N1, who could have addressed assertions from others, including Fouchier and Kawaoka, that publishing the full data could help surveillance efforts. Echoing a point he has made earlier, he said experts from the UN Food and Agriculture Organization and other groups have told him that without major new resources, the data would not fundamentally change surveillance and control practices in affected countries.

On another point, Osterholm said the security briefing that the board heard was “one of the most incomplete and, dare I say, useless classified security briefings” he had ever heard. The briefing did not address the risk of efforts by “rogue scientists or irresponsible researchers” to replicate the experiments in labs without proper biosafety precautions, or the risk of an attempt by eco-terrorists to disrupt animal production by releasing a more-transmissible H5N1 virus in swine.

He also complained that the meeting included no “data-related presentations” on possible use of the mutation data to develop vaccines and antivirals, a prospect that leading experts have been skeptical about.

A primary lesson of the meeting, Osterholm wrote, is that the NSABB must “involve disinterested subject matter experts to provide technical advice.” He added that the life science community should look critically on the “relative lack” of expert input from those without a direct interest in the board’s decisions.

He concludes his letter by saying that the board’s recent experiences represent just the beginning of conflicts over the publication of research findings that could be misused to do harm. “It is unfortunate that the current NSABB action just kicked the can down the road to the next manuscript,” he said.

According to the ScienceInsiderstory, Susan Ehrlich, a retired judge and NSABB member who also voted against publishing Fouchier’s full manuscript, said Osterholm’s letter “thoughtfully presents very valid points, ones that warrant further and serious discussion.”