November 20, 2012

Moratorium on Dual-Use Influenza Research Continues, As Does Debate

During most of 2012, a voluntary moratorium on high-risk H5N1 influenza virus experiments has been in place, following a controversy last winter. At that time, it was revealed that two laboratories had succeeded in creating apparently pandemic-capable H5N1 influenza strains, and were on the verge of publishing their research. The post-9/11 climate in the U.S. had seen the establishment of the National Science Advisory Board for Biosecurity (NSABB) to oversee and advise NIH on dual-use research (potential information, techniques and materials that can be used for benign or malicious purposes). A 2004 National Research Council (NRC) report had called for a more exacting institutional review of grant proposals for “experiments of concern” – that would have included these projects, as they are called "gain of function" experiments - the research produces a more, not less, dangerous virus. Last year, as concern grew over the announcement that new pandemic-level viruses had been produced in a laboratory, an immediate sense of crisis ensued, with the NSABB recruited to advise the journals regarding the suitability of publication. The debate focused on whether publication details should be released or curtailed (details included which DNA mutations made the influenza virus more deadly). There was no official attempt to shut down publication; however, the NSABB initially recommended that the scientific journals decline publication. It later reversed course and endorsed the publication of one in full (here), and one redacted (here).

Further, an international effort by influenza researchers led to agreement on a voluntary moratorium on gain-of-function experiments with H5N1. Their statement declared a “voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals.” This moratorium continues to be in place (and it echoes the 1975 Asilomar conference declaration of a voluntary moratorium on some recombinant DNA research). In July, Dr. Anthony Fauci (director of NIAID, which funded the initial research) had argued for a continued pause. A more recent debate over the continuing need for such a pause occurred in the journal mBio (American Society for Microbiology, ASM). Proponents of restarting such work argue that pandemic preparedness requires anticipating how the influenza virus can adapt and become more dangerous; others caution more delay and cite a combination of biosafety and dual-use research concerns. What’s clear is that these issues are not new and are not resolved; they were certainly anticipated by 2001 as the anthrax attacks raised the stakes for domestic terrorist incidents involving pathogens. As suggested by the 2004 NRC Report, NIH needs to frontload a dual-use review process at the level of funding decisions; such a review could authorize funding if the biosecurity measures are satisfactory but proactively manage a publication strategy, depending on results. Further, the mandatory physical security for such research (containment) needs to be standardized (it is not) before such work is funded. We might be on the verge of more official response to these unresolved questions. At the upcoming NSABB meeting next week, the committee will be discussing dual use research guidelines and NIH funding criteria for high-risk H5N1 influenza research.

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