April 24, 2012

H5N1 Influenza Fallout Continues

More developments have occurred in the wake of the recommendation of the National Science Advisory Board for Biosecurity (NSABB) to endorse publication of two scientific papers which reported the construction of possibly pandemic-potential H5N1 influenza viruses. The full NSABB report has been released and the dissension in the board is noted, including scientific disagreement over the danger of the actual viruses and disagreement over whether the manuscripts were “enabling” and whether publication of the details of the virus were likely to contribute to public health surveillance efforts. There is a nod to the likelihood that similar controversies will reoccur (for example, as the board notes, other “gain-of-function” experiments that introduce new capabilities into influenza viruses). The report states that “the Board also recognizes that research findings will likely emerge in the very near future that should not be widely disseminated because of a high risk of misuse but that nevertheless should be made available to certain researchers and public health officials around the world who have a legitimate need to know.” This suggests that pressure will be brought to establish a dissemination track that can be activated for DURC research (and such a mechanism could allow a broader evaluation of risk than just an NSABB review). Such efforts have been discussed and were particularly resonant in the immediate post-9/11 period (see a report prepared for Congress in 2003, discussing the possibility of using “classified” or “sensitive” designations could invoke publication restraints). For example, in 2005, researchers succeeded in reconstructing the infuenza virus that caused the 1918 pandemic. The NSABB reviewed and endorsed the publication of the reconstructed 1918 influenza virus in 2005, but some reporting from that period is certainly evocative of where we are now: “As part of this process, the Board transmitted several recommendations to Secretary Leavitt: One was that the manuscripts needed modifications to explain the health benefits of the research to the public. Another was the need to amplify the discussion of the measures taken to protect researchers and the public from accidental exposure or inappropriate access to the virus. The Board also recommended the development of additional Federal biosafety guidelines and a Federal regulatory framework for controlling access to the 1918 virus. Subsequent to these discussions, the virus was added to the Select Agent list. Lastly, the Board recommended development of a comprehensive communication plan for public dissemination of this type of information.” Additionally, the recent NSABB recommendations have now been formally accepted by the National Institutes of Health and forwarded to the Secretary of Health and Human Services (the NSABB is advisory to the NIH, which itself is overseen by HHS). And there is more. All of the attention to this newly developed influenza virus emanate from the concern over the “dual-use” character of the research – both useful for medical and scientific purposes, but also susceptible to nefarious use as a bioterrorist agent. Thus, NIH has also conducted a contemporaneous review of possible dual-use research projects and issued a new policy which aims to “establish regular review of United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC).” Thus, NIH is signaling that it does not want to be caught by surprise when the next manuscript of concern emerges. The legislative branch is not left out (see earlier story). This week, the Senate Committee on Homeland Security and Governmental Affairs will hold a hearing on government sponsorship of this research and the publication consequences, featuring speakers from both NIH and NSABB. And finally, Representative Sensenbrenner has renewed his demands for more information from NIH regarding the NSABB process, noting that one NSABB member has issued a critique of the review process as not providing an even-handed review of the risks and benefits of publication. 

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