Fuller Story of H5N1 Mutations Studies Now Publicly Available

The journal Science has published the second of two papers describing methods to make mutated H5N1 influenza transmissible between humans.

The journal Science has published and made publicly available the second of two NIH-funded studies documenting efforts to make mutated H5N1 avian influenza virus transmissible between humans, effectively ending debate over the controversial decision to delay their publication out of concern terrorists might use the information.

Science chose to publish a special H5N1 issue and made its contents available online.

An account of the episode, co-written by Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases within NIH, and NIH Director Dr. Francis S. Collins, explains what the scientific community and NIH learned from it. An accompanying commentary also explains how fears sparked by media coverage when publication was stopped were overblown: One of the authors was asked by Science reviewers to supply lethality data, and when he did, it was reported that the transmitted virus had killed the ferrets involved in the experiment. However, ferrets that inhaled airborne droplets of the mutated virus survived –- and because this is the way people could be exposed, this suggests humans are at less risk than the earlier reports suggested. The animals that died instead had the virus administered directly to their tracheas, the commentary explains.

The first study already was published by the journal Nature.

Fauci and Collins write that manuscripts describing the studies "have generated an unprecedented degree of discussion, concern, and disagreement among scientists, as well as the public, regarding whether the experiments should have been performed in the first place and whether they should be published in their entirety. Major sources of concern have been that the results might be used by bioterrorists to harm the public or that the virus might accidentally escape and cause a pandemic."

They say this episode triggered a new federal policy, announced in March 2012, requiring formal risk assessment and regular review of life sciences dual use research of concern. "Furthermore, as a result of the public discussion of these two manuscripts, major gaps in our knowledge of influenza became painfully obvious," they add. "For example, there was considerable scientific debate about how well data from the ferret model can be extrapolated to understand influenza virus transmission and pathogenesis in humans. An H5N1 virus strictly adapted for ferret transmissibility may not be entirely relevant to humans. Moreover, although it is likely that the officially reported 60% case-fatality rate for human H5N1 influenza is artificially high (because nonfatal cases are less likely to be reported), there are limited surveillance data on which to base a more accurate estimate. NIH has begun a dialogue with the influenza research community about addressing these and other questions and will initiate a more strategic approach to defining the research gaps that must be addressed in order to responsibly move the field forward. In addition to identifying research gaps, the discussion of these manuscripts underscores the important practical issues of implementing rapid turnaround time between virus isolation and sequencing to provide real-time surveillance."

Fauci and Collins said a clear lesson is that civil society must be involved in the dialogue early on. "Clearly, research should be conducted and published only if the potential benefits to society outweigh the risks to national security and the potential harm to society," they conclude. "The risk/benefit calculation for certain experiments and their communication is not always obvious, and the current experience reflected considerable disagreement even in the scientific community. The ultimate goal of the new U.S. government-wide DURC policy is to ensure that the conduct and communication of research in this area remain transparent and open and that the risk/benefit balance of such research clearly tips toward benefitting society. The public, which has a stake in the risks and the benefits of such research, deserves a rational and transparent explanation of how decisions are made. It is hoped that the upcoming dialogue related to the new DURC policy will be productive. A social contract among the scientific community, policy-makers, and the general public that builds trust is essential for success of this process."

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