After a full day of briefings and another of deliberation, the board voted. The members present at the meeting unanimously recommended publication of the Kawaoka paper and voted 12–6 in favour of publishing Fouchier's.
Few came out of the meeting happy. Some were still unsure about how dangerous Fouchier's virus really was. “Even the 12 who voted in favour of publication were uneasy about this uncertainty in the virus,” says Keim, who declined to reveal his vote. Relman, who voted against publication, says that the process felt unbalanced and that he didn't have enough time to assess some new data presented there that had not yet been peer reviewed. “I do think questions should be asked about the manner and process by which we were asked to perform this reassessment,” he says.
Osterholm asked some of these questions in a sharply worded letter to the NSABB and Amy Patterson, the board's director at the NIH, a week and a half after the meeting. (The letter was leaked to Science and Nature days later.) In it, Osterholm said that the presentations given at the meeting were one-sided and designed to favour full publication of the articles. He said that Fouchier had revealed at the meeting an additional mutation that makes H5N1 both transmissible through the air and deadly. This work “surely must be considered as a candidate for the next manuscript to be before the NSABB for review”, wrote Osterholm, who worried that all the same problems would come up again. In her response to the letter, Patterson respectfully disagreed with Osterholm's complaints. But by this point, the spat had started to attract the attention of law-makers. Congressman Jim Sensenbrenner (Republican, Wisconsin) wrote letters to the NIH and to the White House asking how decisions about the research were reached.
People within the NSABB, and outside it, now say that the board did its best in a highly complex situation. But many point a finger at a flawed mechanism for identifying and dealing with dual-use research. “Almost at every step the system isn't working very well for these projects that raise serious concerns about biosecurity,” Fidler says. The most pressing question is why the research wasn't flagged up earlier for scrutiny.
The answer: the policy simply wasn't in place. In its 2007 report, the NSABB recommended that the federal government develop guidelines and implement a code of conduct to help institutions and researchers to report potential risks at the earliest stage of project development. It also recommended the development of strategies for communicating sensitive research, including restricted publication. These recommendations went largely unheeded because scientists resisted the introduction of cumbersome new practices. “We got all worried about the possibility of these threats,” says Fidler, but when it came to imposing regulations on research, “we tended to back off”.
Now, the flu controversy has forced the US government's hand. On 29 March, while the NSABB was being briefed, it released a policy that requires federal agencies to identify and monitor research projects they fund that tick boxes on the 'deadly sins' list. Tom Inglesby, who directs the Center for Biosecurity of UPMC in Baltimore, Maryland, welcomes the new policy. “It would be much more preferable for these decisions to go on at the beginning of this experimental process. It's more fair to the scientists, more fair to their institutions, more fair to the journals and more fair to the NSABB,” he says.
Keim, however, points out that the policy does not require review by disinterested parties. “These are decisions that need to be made in the open with input from different segments of our society,” he says. It may be too much to expect scientists to coolly evaluate the risks of their own research against the benefits they gain personally from publication. And even if regulatory changes do take root in the United States, international agreement will take years to solidify. Keim and several others at the NSABB say that publishing with controlled access to certain data would still have been the preferred option for the H5N1 papers, but the challenges extend well past US borders.