Charting New Waters in Biosecurity

Research that can either save lives, by helping to develop new vaccines, or cause considerable harm by releasing biohazardous agents (either intentionally or unintentionally) on an unsuspecting public – that is at the heart of a major dilemma currently facing the biosecurity world. Earl Stoddard, the Public Health Program Manager for the University of Maryland’s Center for Health and Homeland Security, wrote an informative article for the 4 April 2012 issue of the DPJ Weekly Brief on such “dual-use” biomedical research. His principal thesis in the article is that this type of research, even though well motivated and intended to be objective scientific exploration, could nonetheless lead to possible harmful results.

The primary example used in Stoddard’s article was the tentative publication of research carried out by Dr. Ronald Fouchier at Erasmus Medical Center in The Netherlands and his colleagues on the transmissibility, between mammals, of the H5N1 avian influenza virus. The National Science Advisory Board for Biosecurity (NSABB) recommended last year that Fouchier’s article be published, but in a redacted form (to avoid the sharing of critical information that might be used with malicious intent – by terrorists, for example).

However, even as Stoddard was preparing his article for publication in the DomPrep Journal, the NSABB held another meeting (on March 29-30) to reconsider its earlier decision. This second meeting was called primarily to review revisions that Fouchier and his colleagues had made to the original manuscript.

On April 11, the NSABB released its final “Findings and Recommendations” report on Fouchier’s research. In that report, the board members agreed that:

• Pandemic influenza preparedness requires global cooperation;
• Appropriate conditions were used to conduct the research carried out by Dr. Fouchier;
• Policies for the oversight and communication of dual-use research that could cause legitimate scientific concern are urgently needed; and
• An appropriate mechanism for the dissemination of such sensitive scientific information is urgently needed.

Cautions, Concerns, Areas of Disagreement

There were, on the other hand, two key issues on which at least some of the board members disagreed. First, most members of the board said they believe that Fouchier’s revised article does not contain data that would immediately and/or directly be useful to terrorists or other evildoers – but other members of the board believe that the article does contain such harmful information. Second, although there was a general consensus that the data in the revised article could in fact benefit public health and surveillance efforts, a few members disagreed on the relevancy and/or immediate usefulness of that same data.

The NSABB concluded, therefore, that:

• The data, methods, and conclusions presented in the revised manuscript should be published – but with additional changes (to eliminate the potentially harmful uses of certain information);
• National and international policies must be developed as soon as possible for the oversight and communication of information relevant to dual-use research that might raise similar concerns in the future; and
• An effective and appropriate mechanism for controlling access to sensitive scientific information is needed – on an urgent basis.

An Additional Mutation, a Dual-Use Cookbook, the Proverbial Straw

To add to the “dual-use” debate, on April 12, Dr. Michael Osterholm, Director of the Center for Infectious Disease Research and Policy, and a member of the NSABB himself, wrote a letter of concern in which he described the March 29-30 meeting that he attended as being “one-sided.” Significantly, Osterholm also stated that his previous recommendation in favor of publishing the revised version in full has changed. He expressed particular concern about setting a precedent for future research and publication, and mentioned as an example Fouchier’s other work, which is likely to appear in a future article, on an “additional mutation that now confers H5N1 transmissibility between mammals without ferret passage.”

Coincidentally, to address other concerns that have been raised about such dual-use research, the Obama administration spelled out a number of highly relevant new regulations on 29 March 2012 – in a position paper (“United States Government Policy for Oversight of Life Sciences Dual-Use Research of Concern”) that is now available on the National Institutes of Health’s Office of Biotechnology Activities website.

The purpose of such oversight, officials said, is to avoid similar controversial situations in the future in which research is carried out and a report on that research is ready for publication before a red flag is raised. By providing a “pretty complete cookbook,” as Osterholm himself pointed out, “the next mutation paper [may well] prove to be the straw that breaks the camel’s back.”

For additional information on: “Dual-Use Disasters: Lessons for Preparedness Professionals,” by Earl Stoddard, visit https://www.domesticpreparedness.com/articles/dual-use-disasters-lessons-for-preparedness-professionals

Letter by Michael T. Osterholm, visit http://news.sciencemag.org/scienceinsider/NSABB%20letter%20final%2041212_3.pdf

Findings and Recommendations of the NSABB, 11 April 2012, visit https://www.nih.gov/sites/default/files/about-nih/nih-director/statements/collins/03302012_NSABB_Recommendations.pdf

President Obama’s “United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern,” visit https://obamawhitehouse.archives.gov/blog/2013/02/21/proposed-policy-targets-dual-use-research-concern

Earl Stoddard’s blog on “CHHS Weighs In on Obama’s New Plan for High-Risk Biological Research,” visit http://www.mdchhs.com/blog/chhs-weighs-obamas-new-plan-high-risk-biological-research