26 April in Washington DC, US Senator Joseph Lieberman of Connecticut revealed that his grandmother was killed by influenza during the 1918 pandemic. This was one reason he has been so interested in a pair of yet-to-be-published papers on laboratory-created H5N1 avian influenza strains that could conceivably prove many times more deadly than the 1918 flu. The other reason for his interest is that he chairs the committee on Homeland Security and Government Affairs, which had called a hearing to understand how decisions were made about the research’s potential use as an agent of bioterrorism. At the hearing, officials involved in making the decision to publish the research were queried about a letter that was leaked to the press two weeks ago. In the letter, Michael Osterholm, a member of the National Science Advisory Board for Biosecurity (NSABB), accused the U.S. government of stacking the decks in favour of full publication during a crucial closed door meeting in March at which the NSABB was asked to re-evaluate the papers.
Paul Keim, acting chair of the NSABB, who testified today, said “I view it as a very constructive type of communication. It was unfortunate that it was leaked to the public… that made it very hard to have a constructive conversation about it.” He went on to say that he agreed with Osterholm’s contention that there was a bias in the list of witnesses presenting evidence for and against full publication. The presenters included the two researchers whose teams had performed the research and one of their collaborators. “But the bias inherent in these witnesses was not very important,” Keim says, noting that the board members were able to ask them tough, probing questions.
As for a classified security briefing that Osterholm referred to in his letter as “one of the most incomplete and, dare I say, useless classified security briefings I’ve ever attended,” Keim responded that they were able to ask fewer questions of these presenters. “That was an environment where the board was perhaps a little bit naïve.” But the analysis they provided spoke to the political ramifications of not publishing, which Keim says were important in revising their decision. Though he would not speak specifically about these ramifications, he was likely he was referring to the Pandemic Influenza Preparedness framework, a delicate agreement hammered out by the World Health Organization in 2011 to enhance sharing of influenza data and research internationally. Assigning access to the mutant flu data to only some individuals may have jeopardized that agreement.
Anthony Fauci, director of the National Institute for Allergy and Infectious Disease, said he didn’t think that the NSABB board members were likely “to be influenced by what they might perceive as a bias.” He stated that he did not agree with most of Osterholm’s complaints and noted that a point-by-point response has been drafted and circulated to NSABB members. He later said that he expected it would be made public.
Some attention was paid at the hearing to a recent policy announcement on March 29, which many see as a stopgap measure to address some of the concerns the fight over these papers has raised. The policy, drawn up and issued by multiple government bodies called for a close assessment of all research programmes being funded by the US government that might have worrisome dual use implications.
Daniel Gerstein of the US Department of Homeland Security
said that of 225 experiments per year funded within the department, none met the criteria of dual use research of concern that the NSABB has proposed said that the department had already been reviewing its funded research. He explained that of about 225 experiments funded per year, 200 fell into what the department calls Tier 1, that don’t rise to the level of concern. In Tier 2, which “could perhaps have some issues with perception” they have 12 to 15, and in tier 3, the highest category of concern there are five to 10.* Fauci noted, as reported earlier, that ten programmes funded by the NIAID met the criteria and will need to be monitored.
Everyone testifying lauded the policy as a step in the right direction, but Tom Inglesby, director of the Center for Biosecurity at the University of Pittsburgh Medical Center used his testimony to call for more measures. He called for extending the current voluntary moratorium on this kind of research, limiting this kind of work in the future to a small number of labs (possibly BSL-4 labs as Canada has done), developing clear red lines for research that should not proceed and requesting that an independent body, such as the National Academies of Science assess the impacts of government regulation on the practice of science, so that bureaucratic burdens can be managed appropriately if new policies are put in place.
Keim noted after the hearing had ended that the March 29 policy still does not include assessment by “outside eyes,” something he thinks would be crucial in assuring that biases don’t creep in and mentioned that the NSABB still hopes to see a workable way to publish only parts of a research program and release full details on a need to know basis.
Nevertheless, when Lieberman, who was the only Senator present to question the panel asked if there was any legislative assistance that Congress could provide to help improve biosecurity oversight, all panellists responded that there was not. Lieberman says that he was satisfied and comforted by the testimonies. But officials still must contend with pointed questions from US Representative Jim Sensenbrenner of Wisconsin, who has been doing some sabre rattling of his own with respect to how prepared the NIH was to deal with dual use research issues, asking:
1. Why did NIH request that the NSABB reconsider its previous decision?
2. What was done to ensure that the NSABB was briefed by disinterested subject matter experts?
3. What steps are you taking to investigate the recent allegations of bias?
4. Which agencies and officials participated in the inter-agency policy process that created the “Policy for Oversight of Life Sciences Dual Use Research of Concern?
5. What mechanisms does NIH have in place to ensure that agencies comply with the new oversight policy? Is compliance with the policy mandatory?
The NIH has until 18 May to respond.
* Correction appended April 27 upon review of transcript. Thanks to the DHS for pointing out the error.