Still, the board struggled with its decision. At first, says NSABB member Arturo Casadevall, a microbiologist at the Albert Einstein College of Medicine in New York, “I was very uncomfortable with the idea of redacting information because I think that it's a slippery slope”. But the data and expert analysis assembled by the board convinced him that what Fouchier and Kawaoka had done was too easy to repeat. “We just didn't think it would be a good idea to put a recipe out there,” he says. Michael Osterholm, a public-health researcher at the University of Minnesota in Minneapolis, emphasized his support for the research, but stressed the precautionary principle. Once the work was published, it could not be taken back. “You can't unring a bell,” he said on several occasions.
In late December, the US Department of Health and Human Services, which oversees the NIH, announced that it would follow the NSABB's advice. The response was severe, says Keim. “That redaction approach has been universally panned,” he says. “The investigators hated it, the people who weren't going to get the data hated it. The government hated it because they couldn't figure out how to do it.”
Meanwhile, the NSABB's members were scrambling to make clear that the issues needed international discussion. In mid-February, Kawaoka and Fouchier presented their work at a closed meeting at the World Health Organization (WHO) in Geneva, Switzerland. They assured the researchers that the benefits — for monitoring wild viruses for potentially dangerous mutations and for vaccine development — outweighed the risks. They also explained that the mutant viruses weren't necessarily lethal to the ferrets, something that hadn't been clear to everyone before. The attendees, mostly academic flu researchers, recommended that both papers be published in full.
In light of the new information, the NIH asked the NSABB to reconsider its position. A workshop was scheduled for 29–30 March.
Second thoughts
The meeting started at 7 a.m. in a sixth-floor conference room of building 31 on the NIH campus in Bethesda. Keim had heard the presentations at Geneva, but still couldn't predict how the rest of the board were going to react. “I was not placing bets either way.” The voting members sat round a conference table, with about 60 administrators, government officials and ex officio members looking on. Everyone was given two hours in silence to review revised manuscripts from Kawaoka's and Fouchier's teams. The researchers had edited the papers to clarify the benefits of the research and to explain the safety measures taken during work with the viruses. Later, they gave presentations. Fouchier was reportedly questioned for two hours.
By this point it was clear that Kawaoka's paper posed less of a threat than Fouchier's because of the low pathogenicity of his hybrid virus. But Relman and other members of the NSABB say that they were not reassured by Fouchier or by the revisions to his manuscript. “There were no new data that for me diminished the evidence for mammal-to-mammal transmissibility and no data that convinced me that the virulence was any less in his mutant viruses than it was in the wild-type parental H5N1 strains,” Relman says.
The board also heard that the practical and political barriers to redaction looked formidable. NIH director Francis Collins told them that export-control rules and freedom-of-information laws in other countries would make it impossible to implement a system for selectively releasing data quickly. Moreover, such a system could jeopardize the pandemic-influenza preparedness framework, an international agreement to share influenza viral samples and information that had been hammered out in 2011 by the WHO after years of debate. For officials in countries such as Indonesia, where poultry farmers have faced financial ruin because of H5N1, a decision to redact information sounded like a decision to withhold it. It became clear to the board that redaction was effectively off the table, meaning that the NSABB could vote to publish the paper in full, or not at all.
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