Statement by NIH Director Francis Collins, M.D., Ph.D. on the NSABB Review of Revised H5N1 Manuscripts

On March 29 and 30, the National Science Advisory Board for Biosecurity (NSABB), an independent expert committee that advises the National Institutes of Health (NIH), the Department of Health and Human Services (HHS) and other Federal departments and agencies on matters of biosecurity, convened to review unpublished revised manuscripts describing NIH-funded research on the transmissibility of H5N1 influenza virus — the strain commonly referred to as "bird flu." One manuscript, “Aerosol transmission of avian influenza A/H5N1 virus,” contained research findings by Dr. Ron Fouchier. The other manuscript, “Haemagglutinin mutations that confer human-type receptor recognition and support respiratory droplet transmission of H5N1 influenza A virus in ferrets,” contained research findings by Dr. Yoshihiro Kawaoka. To clarify the results of their research findings, both authors revised their manuscripts from versions reviewed earlier by the NSABB. The NSABB reviewed the revised manuscripts to make recommendations as to whether, and if so how, they should be communicated.

This line of research is critically important because it will help public health officials understand, detect, and defend against the emergence of H5N1 virus as a human threat, a development that could pose a pandemic scenario. The value of this research notwithstanding, certain information obtained through such studies has the potential to be misused for harmful purposes — a characteristic associated with what is referred to as “dual use research of concern.” These particular manuscripts include the important finding that the H5N1 virus has greater potential than previously believed to gain the capacity to be transmitted among mammals, as assessed by experiments with ferrets. The manuscripts describe some of the genetic changes that appear to correlate with this potential.

During its March meeting, the NSABB took into account the new and clarified information in the manuscripts, additional perspectives provided by influenza biology experts, highly pertinent but as yet unpublished epidemiologic data, and relevant security information.

After careful deliberation, the NSABB unanimously recommended the revised manuscript by Dr. Yoshihiro Kawaoka be communicated in full. The NSABB also recommended, in a 12-to-6 decision, that the data, methods, and conclusions presented in the revised manuscript by Dr. Ron Fouchier be communicated fully after a number of further scientific clarifications are made in the manuscript. The recommendation to communicate the research was based on the observation that the information in the revised manuscripts has direct applicability to ongoing and future influenza surveillance efforts and does not appear to enable direct misuse of the research in ways that would endanger public health or national security.

The HHS Secretary and I concur with the NSABB’s recommendation that the information in the two manuscripts should be communicated fully and we have conveyed our concurrence to the journals considering publication of the manuscripts. This information has clear value to national and international public health preparedness efforts and must be shared with those who are poised to realize the benefits of this research.

The Secretary’s decision takes account of relevant U.S. law, international obligations, and a rigorous analysis of the benefits and risks of publication. The work in the Netherlands by Ron Fouchier is subject also to laws and regulations of the Netherlands, and the Dutch government is conducting its own review of Dr. Fouchier’s work. We respect that process and value the dialogue we have with Dutch authorities toward our common goals of encouraging scientific inquiry, advancing global health, and protecting the safety and security of our populations and the wider global community.

In addition, the recently released Federal policy on dual use research of concern is an important step in enhancing the oversight of federally funded life sciences research going forward. Through implementation of this policy, the U.S. Government aims to preserve the benefits of vitally important life sciences research that holds the promise of enhancing quality of life for all of us, while minimizing the possibility that the knowledge, information, products, or technologies provided by such research could be misused for harm.

I am grateful to the NSABB members for the time and effort they have dedicated to considering the complex issues pertinent to dual use research generally, and for working so tirelessly on developing the most thoughtful recommendations possible regarding these two manuscripts.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health