Much of emergency preparedness focuses on reducing, preventing, and/or mitigating risk. However, there are certain circumstances whereby a risk is actually created in order to help mitigate or diminish a second, and even greater, risk. Whether that approach is reasonable and/or necessary has caused considerable debate, which is focused primarily on the value of “dual-use” biomedical research – a major subject of discussion at an eBriefing presented on 2 February 2012 by the Emerging Infectious Diseases & Microbiology Discussion Group of the New York Academy of Sciences.
Dual-use research is essentially defined as scientific exploration of the tools, products, and/or findings that could be used in benevolent and productive ways to improve human health or, alternatively, cause significant harm if accidentally or intentionally released upon the public. It seems clear, though, that – despite the fact that the debate between the scientific and homeland security communities over the safety and benefits of such research is extremely important – the emergency preparedness community also must focus on the potential impact that dual-use laboratories have on local planning and preparedness efforts.
The H5N1 Avian Influenza Episode In December 2011, the scientific journal Science approached the National Science Advisory Board for Biodefense (NSABB) to discuss a manuscript being considered for publication. The research that generated the manuscript in question involved laboratories, in the United States and Denmark, that had successfully adapted the H5N1 avian influenza virus to be transmitted through airborne means to ferrets – i.e., the animal model that most closely resembles human influenza infection.
The Science editors were concerned about the potentially malevolent uses that this research could have and for that reason sought guidance on the appropriateness of its full publication. Ultimately, the NSABB recommended publication of an amended and somewhat truncated article in which information about the scientific methods used had been deleted – thereby, it was and is hoped, preventing replication of the experiments for unscrupulous or even criminal purposes.
The U.S. and Denmark studies were funded principally through federal grants provided by the U.S. National Institutes of Health (NIH) and, therefore, probably should have received closer scrutiny long before the research had progressed to the point of publication. This perceived lack of proper oversight has raised concerns about other research of a similar nature that might already be ongoing in academic or private laboratories both in the United States and in a number of other nations.
Benefits and Risks of Dual-Use Research Continuing with the H5N1 example: The potential medical benefits gained by a better understanding of the virus are clear. As of 26 March 2012, there had been 352 deaths – out of 598 human cases of H5N1 reported to the World Health Organization (WHO); that number translates into a mortality rate of close to 59 percent.
Fortunately, the number of human infections has been relatively limited, and the virus has thus far not adapted well enough in humans to spread efficiently from one person to another. However, if the virus does start to mutate in such a fashion, the public health and preparedness communities could be facing a pandemic the consequences of which might closely resemble those caused by the 1918 Spanish Flu – estimated by WHO to have killed 20 to 40 million, or more, worldwide. For purposes of comparison, the more recent and much less severe 2009-2010 H1N1 pandemic, according to WHO, had killed just over 18,000 people worldwide as of the end of May 2010 (there is some disagreement on the final total, but it seems likely it will not be much higher than the WHO estimate).
Research such as that soon to be reported in Science might well provide valuable insights into possible evolution of the virus into a form that could lead to more efficient human transmission. Such research therefore might give U.S. public health officials the ability to analyze current and future strains in the time needed to detect any shift that could lead down such a dangerous path. Here it also should be noted that the laboratory research already carried out produced strains that: (a) will allow medical professionals to better understand how an H5N1 pandemic might play out in humans; and (b) might lead to the advance development of a novel vaccine and/or other treatments.
On the other hand, though – and this also should be emphasized: the public health benefits might indeed be evident, but so are the risks. Human error can and in fact has in the past led to lethal laboratory accidents – one recent example was the 2009 death of a 60-year-old researcher in Illinois who contracted the plague after a laboratory exposure. In the case of a highly pathogenic and infectious disease such as influenza, of course, the consequences of such laboratory exposure are considerably higher.
Another factor to be considered is that such research also might serve, unintentionally, as “proof of principle” for potential terrorist organizations or rogue states to begin work on building new weapons of mass destruction. For that reason alone it is obvious that, while recognizing that the NSABB recommended limiting publication of the methodology used in the H5N1 research, such a recommendation, even if followed to the letter, does not necessarily and/or completely eliminate the risks involved.
New Challenges for the Preparedness Community Given the demonstrable risks involved, dual-use research represents an ongoing and often under-appreciated threat that public health, emergency management, and preparedness professionals must always keep in mind in their risk-analysis judgments and decisions. The most significant challenge in this area is simply to maintain constant awareness. Domestic laboratories are mandated under federal law to self-identify through the National Select Agent Registry – which is jointly maintained by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). However, the information possessed and/or provided to those two agencies does not necessarily trickle down to state and local responders – or even to the political leaders legally responsible for making the final go/no-go decisions.
Nonetheless, when a fire department vehicle or ambulance arrives at the scene at a laboratory accident, the responders themselves also must be fully aware of any potential exposure risks involved. Similarly, senior hospital officials should be provided with the information needed, and available, about any biological hazards within their communities – even if those hazards are maintained in well protected laboratories and/or other secure environments.
Some states have a direct registration process for laboratories to ensure that they have access to current information about the various agents being studied within their states. Maryland, for example, maintains a Biological Agents Registry (BAR) program in its Department of Health and Mental Hygiene’s Office of Laboratory Emergency Preparedness and Response (OLEPR). The BAR program requires that all laboratories – both academic and private-sector – register with the state and report, in writing, whenever changes are made to a facility’s select agent research inventory. This information is then relayed to specific state, local, and municipal officials in an effort to improve and expand overall situational awareness. It is recognized, of course, that the open sharing with the public of the types and locations of certain agents might present a security risk, but providing limited and appropriate access to such information is an important aspect of preparedness.
Risks vs. Rationale – But a Murky Conclusion Efforts to improve communication between and among the public, first responders, and the laboratory community can occur even at the local level. For example, Frederick, Maryland, is home to Fort Detrick, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), and its supporting private laboratories. In November 2010, the City of Frederick and the Frederick County Board of Commissioners established the Containment Laboratory Community Advisory Committee (CLCAC).
Since then, the committee has defined its priorities to include: (a) establishing a strong relationship between local governments and their military counterparts at Fort Detrick; (b) informing group members about the missions, risks, and benefits of the research being conducted within their community; and (c) providing an avenue for community feedback, questions, and concerns. The CLCAC membership includes local and municipal government officials, a number of private citizens, and representatives of the laboratory community. The Committee also has started to develop the information needed to reassure the general public that residents and other citizens are kept fully informed about the ongoing research being carried out within their community.
Dual-use laboratories present yet another risk for potential emergencies, but they also afford the preparedness community the rationale needed forentifying and engaging another segment of its community in emergency preparedness endeavors – i.e., the research laboratories, which are usually willing partners. One recent example of this type of engagement was through the Regional Center for Excellence in Biodefense and Emerging Infectious Diseases (RCE) program – which is administered by the National Institute of Allergy and Infectious Diseases (NIAID). The RCE program funds basic and translational science research in biodefense and emerging infectious diseases. The program also establishes the requirement, as a funding commitment, that the RCEs engage local, state, and regional partners in public health emergency preparedness matters, particularly by serving as subject matter experts on various biological events.
The RCEs have engaged in public health laboratory capacity building and community education by providing expert advice. Thus, although the future of the program’s funding remains somewhat murky (in large part because of already difficult funding restrictions), the RCEs serve as an excellent model for engaging academic laboratories in their joint venture in emergency preparedness. Searching for similar opportunities will offer the preparedness community improved collaborations, an earlier as well as more comprehensiveentification of local risks, and, it is hoped, new partners in emergency preparedness.
For additional information on: The February 2012 eBriefing presented by the New York Academy of Sciences, visit http://www.nyas.org/Events/Detail.aspx?cid=f7d2e65c-9f8d-4418-b25e-bff21bb0a6cb
H5N1 Avian Influenza, visit http://www.who.int/influenza/human_animal_interface/en/
National Select Agent Registry, visit http://www.selectagents.gov/
Maryland Biological Agent Registry (BAR), visit http://dhmh.maryland.gov/laboratories/docs/BAR_FAQs.pdf
RCE Programs, visit www.niaid.nih.gov/labsandresources/resources/rce/
The Frederick, Maryland, Containment Laboratory Community Advisory Committee (CLCAC), visit http://www.cityoffrederick.com/index.aspx?NID=127
Earl Stoddard is the Public Health Program Manager for the University of Maryland Center for Health and Homeland Security (CHHS). In that post, his responsibilities include overseeing many of the Center’s public health efforts, working with regional partners on public health preparedness efforts, and improving the interface between the public health and emergency management communities. He also assists several local governments, hospitals, and regional organizations in identifying shortfalls, improving planning, and strengthening their collaboration and communications efforts with their partners.