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Should the Moratorium on Enhancing H5N1 Transmissibility End?

How can scientists safely conduct avian flu research if the results could threaten or save millions of lives? A series of Commentaries in mBio this week presents some important perspectives on the type of H5N1 influenza research that started (the ongoing) widespread controversy among both scientists and the public one year ago. The authors of five Commentaries and one Editorial argue the cases both for and against lifting a voluntary research ban on experiments to enhance the ability of the H5N1 virus to move from mammal to mammal, so-called gain-of-function research, and discuss the level of biosecurity that would be appropriate when that research eventually moves forward.

In January 2012, a group of influenza researchers agreed to “a voluntary pause on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals”. Enhancing and analyzing the transmissibility of the H5N1 virus could, on the one hand, provide insights that could help tamp down an outbreak of H5N1 that may arise in the future, or, on the other hand, it may provide a roadmap for anyone who seeks to deliberately bring about an influenza pandemic or lead to an inadvertent release of a virus with enhanced transmissibility. The research moratorium continues today as scientists and regulatory agencies around the world grapple with how to conduct research that could lead to such paradoxical results.

Weighing in on the matter are:

• mBio Editor in Chief, Arturo Casadevall of the Albert Einstein School of Medicine, and Thomas Shenk of Princeton University and Chairman of ASM’s Publications Board, outline the dilemma at hand in their Editorial: research on how the H5N1 virus can “learn” to transmit easily from animal to animal could help prevent flu pandemics or provide the very seed of the next global pandemic. Casadevall and Shenk also highlight the need for scientists to establish a clear rationale for gain-of-function experiments and suggest that it may be advisable to alleviate some of the concerns and risks involved by creating safer study systems to answer the same questions.

• Ron Fouchier of Erasmus MC Rotterdam in The Netherlands, Adolfo García-Sastre of the Mount Sinai School of Medicine, and Yoshihiro Kawaoka of the University of Wisconsin-Madison, argue that in the eight months since the moratorium was agreed upon, the international research community has had sufficient time to review biosafety and biosecurity measures and that H5N1 transmission studies ought to proceed.

• Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases contributes his voice as a representative of an organization that is a key funder of influenza research. Although Fauci acknowledges that the benefits of gain-of-function research outweigh the risks, he argues that scientists have yet to fully meet their responsibility for engaging the public in weighing these matters and making the case for proceeding. He outlines how the U.S. plans to augment policy guidelines related to “dual use research of concern” like the experiments that began the controversy.

• Marc Lipsitch and Barry R. Bloom of the Harvard School of Public Health explain why they view H5N1 with enhanced transmissibility as a “potential pandemic pathogen”, representing an even greater threat to global health than Ebola and other biosafety level 4 (BSL-4) pathogens. They argue that research on enhanced H5N1 and other potential pandemic pathogens requires a new, more stringent set of guidelines for safety, thorough public discussion of the risks and benefits involved, and global guidelines for laboratory procedures, among other measures to minimize the risk of laboratory-released infections or epidemics.

• Ian Lipkin of Columbia University argues that once research on enhanced strains of H5N1 continues it may be advisable to conduct the work only in BSL-3 Ag laboratories that meet additional, enhanced guidelines for handling agents with pandemic potential. Lipkin proposes that any course should be charted in consultation with and oversight from the global scientific and regulatory community.

• Stanley Falkow of Stanford University provides perspective on the H5N1 research moratorium based on his own experiences with a similar situation in the 1970s, when research in recombinant DNA techniques was halted while a committee of scientists and non-scientists could establish a set of guidelines for conducting the work safely. Falkow argues that research on H5N1 viruses with enhanced transmissibility should move forward once scientists work with the public to establish standardized guidelines using common sense and scientific creativity.

“This is a historic time in science,” says Editor in Chief Arturo Casadevall. mBio has solicited the views of experts in the field, he says, in order to provide a venue for recording the arguments for and against continuing H5N1 gain-of-function research. Casadevall continues, “Society is asking for a pause of research that is perhaps the best defense against pandemics because of concern about both biosafety and biosecurity.” With the research moratorium continuing well past the 60-days that was originally planned, it is time these conflicting views were aired in a public forum, he says.

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