Blog Posts

Op-Ed – Dual-Use Research: Is it possible to protect the public without encroaching rights?

headshottfT. Tosin Fadeyi, Master’s Candidate, Biotechnology (Biodefense and Biosecurity Concentration), University of Maryland University College

For decades, scientists have had reasonable freedom and control over their research and experiments and able to publish and share their work without much inconvenience. The freedom of creativity in the field of science is much like that of an artist – often fueled by an inspiration from other sources, a passion for a unique realm of art (in this case, science), and a natural curiosity. Within reasonable limits, artists and scientists had the world at their fingertips; as long as they weren’t causing a societal disruption or engaging in illegal activity, their work was unregulated and not subject to state interference. Much of the 20th century was filled with astounding scientific advances and rapidly developing technology, as well as concerns for misuse. These concerns persist in the 21st century, as technology and science continue to advance further. With the continued growth of scientific knowledge and technological development, awareness of the risks associated with the misuse of scientific knowledge and new technology has continued to increase significantly – especially in microbiological research.

Microbiological research threats emerged on the public radar when anthrax strains used in the 2001 mailings to several United States government officials and citizens were found to have originated from the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Maryland. While senior biodefense researcher Dr. Bruce Ivins was the primary suspect for the anthrax mailings mainly due to his unauthorized decontamination of several areas of USAMRIID, his involvement is still unknown today. Since then, scientists have been scrutinized for working on certain research topics and published research literature labeled as “sensitive.” Ron Fouchier, a scientist at Erasmus Medical Center in Rotterdam, Netherlands, completed research and wrote a research paper in 2011 on laboratory-created strains of H5N1 avian influenza[1]. During the course of his research he faced pressure from the Dutch government over the content of the research paper that contained potentially dangerous information that might essentially teach someone how to create synthetic H5N1. In 2012 the U.S. magazine, Science, was to publish the paper until the U.S. government stepped in to block the paper from being published. Eventually Fouchier and the National Science Advisory Board for Biosecurity (NSABB), an advisory committee for the United States government, had come to a compromise about the publication – that it could only be published if sensitive information were removed from the article. After that decision came proposals to create a system only accessible to “responsible scientists” where the removed sensitive information could be viewed. But who is responsible for deciding which scientists are responsible? And what makes one scientist more responsible than another? Which qualities would one use to measure how reliable a scientist is: Credentials? Previous research? Educational background? Possession of a criminal record? While it is an interesting point to consider, society can’t make these decisions based on arbitrary methods of identification. There is no way to know if the Harvard educated, award-winning, highly skilled professor with a spotless criminal and driving record is going to be more trustworthy than the man who hasn’t published any major papers, committed a misdemeanor in his freshman year of college, and has not yet been able to contribute anything to the scientific community. In a radio interview for Science Friday, Dr. D.A. Henderson, a distinguished scientist and epidemiologist at the University of Pittsburgh Medical Center’s Center for Biosecurity, pondered what this would mean for the scientific community[2]. Scientists might be turned down for grants or jobs arbitrarily, which would prove to be disruptive to the fundamental tenants of scientific inquiry as well as to the basic rights of those individuals who would not understand why there weren’t chosen for access to the exclusive system.

Upon realization of the possible dangers on publishing certain components of scientific research, the United States government assembled the NSABB, a panel of voting members with expertise in medicine, life sciences, national security, and other related fields. The NSABB assisted in addressing issues related to biosecurity and dual use research in 2004. Decisions made by the NSABB have no legal authority and their findings are strictly advisory. Unfortunately, the majority of scientific work in the United States is funded by a government entity, and refusal to comply with NSABB’s advice could result in the reduction or loss of funding. An NSABB decision, while in the best interest of national security and the safety of our citizens, could have a chilling effect on research and advancement. Knowing that one’s research may be abridged to omit sensitive details, or blocked from publication, could discourage scientists from publishing – or even attempting – certain types of research. History has shown that general open access to scientific research publication contributes to many advancements and scientific breakthroughs. Science is a field in which breakthroughs are built upon past innovations and discoveries. Restricting the publishing of research could negatively impact such scientific progress in the long run.

There is no question that sensitive scientific information needs to be watched closely, but there does not seem to be a plausible solution to the problem at this time. The new restrictions and regulations on scientific research are meant for national security, but at what point does national security encroach on the right of free speech? At what point do we allow national security concerns to impede the scientific process upon which so many societal advancements are based? This debate not only has technical implications, but is an ethical quandary as well.

As is the case with many ethical debates, there is no perfect solution. A sound strategy begins with the heavy involvement of the scientific community in the discussion. Fortunately, members of the scientific community are engaging on this topic. A 2007 study analyzed literature centered around the ethics of biodefense and dual-use research of concern from the Medical Literature Analysis and Retrieval System (MEDLINE) database, which holds bibliographical information for academic science journals. Ten articles met their inclusion criteria, and the study concluded that self-regulation within the scientific community, international cooperation, and increased security were the top three suggestions for minimizing the risks presented by dual-use research[3]. Conscientious self-regulation would allow scientists to oversee their own research and associated literature without concerns of compromising the quality of their publications. Additionally, international cooperation would unify a larger group of scientists who may possess similar concerns against the problem. Finally, better cooperation establishes stronger safety and security measures through focused peer review. Combined, these three measures can increase security and make the misuse of sensitive scientific information more difficult for people with access to it, and with increased safety education and clarity of dual use definitions could further decrease the risks from misusing science.

 

References:

[1] Herfst, S., Schrauwen, E. J., Linster, M., Chutinimitkul, S., de Wit, E., Munster, V. J., & Fouchier, R. A. (2012). Airborne transmission of influenza A/H5N1 virus between ferrets. science, 336(6088), 1534-1541.

[2] Anand, N.S. (Producer). (2012, January 06). Debate persists over publishing bird flu studies [Audio podcast]. Retrieved from http://www.sciencefriday.com/segment/01/06/2012/debate-persists-over-publishing-bird-flu-studies.html

[3] Dolgitser, M. (2007). Minimization of the Risks Posed by Dual-Use Research: A Structured. Journal of the American Biological Safety Association, 12(3), 175. Retrieved from http://www.absa.org/abj/abj/071203dolgitser.pdf

 

Book Review: Bioinsecurity and Vulnerability

Reviewed by T. Tosin Fadeyi

Edited by Nancy N. Chen and Lesley A. Sharp

Contributors: Steven C. Caton, Nancy N. Chen, Joseph Masco, Monir Moniruzzaman, Carolyn Rouse, Lesley A. Sharp, Glenn Davis Stone, Ida Susser, David Vine, and Michael J. Watts.

Bioinsecurity and Vulnerability is an intuitive compilation of writings that explore the hysteria surrounding preparation for a silent threat: biological terror. The essays in this book illustrate the reality of biological preparedness in the 21st century by bringing together previously unacquainted realms like genetic engineering, the military, and accidental disasters around the world. Bioinsecurity features relevant photography to illustrate and enhance the contributors’ discussions.

Rather than focusing on the dangers and possible methods of biological terrorism, these essays confront the current preparedness measures that are gradually becoming a part of routine national security discussions. This book focuses on less discussed biosecurity topics such as body organ sellers in Bangladesh, climate change, and the impact of economics on resilience efforts in state emergencies.

This anthology strays away from the familiar discussions of biosecurity and how to prevent bioterror attacks, disease outbreaks, and other disasters feared to be impending. Instead, it shifts the focus to the impact biosecurity measures have had on agriculture, corporations, and economics in nations across the globe.

Op-Ed – Microbial Forensic Attribution: Where Science Meets International Relations

Christopher A. Bidwell, JD, Senior Fellow for Nonproliferation Law and Policy, Federation of American Scientists & Mark Jansson, Program Manager, CRDF Global.

The U.S. government is making significant investments in bio forensics as a tool for attribution. In order for that investment to pay-off, it must be combined with investments in international collaborations so that the science behind any future attribution claims that may be made are accepted as fact, both in scientific and political terms. To better understand how evidence derived from microbial forensics will be received in international contexts among people with different cultural, professional, and political backgrounds, the Federation of American Scientists convened a daylong workshop involving domestic and international participants with expertise in forensic science, public health, law, and security policy. Additionally, the research team performed a literature review from the legal, life science, and social science realms to both inform preparations for the workshop and to complement the findings derived from it.

Key findings from the workshop were three-fold: (1) using international partners to build trust in the credibility of the messenger (not just the message) is important to fill potential “credibility gaps” that can exist between the United States and other countries; (2) the media content generation, policy responses, and scientific investigation related to a suspected biological attack all operate on competing timelines that can hamper effective communication and decision making; and (3) forensic data will need considerable support from other information sources in order to marshal international cooperation in taking action against biological attack perpetrators.

The literature review explored some of the specific cultural, ideological, and cognitive factors that could affect how foreign audiences will respond to forensic evidence attributing a biological attack to a given country or group. Key findings were that: (1) cultural differences related to conflict resolution can affect the way microbial forensic evidence is received internationally, as some may question the science as a proxy for questioning the overall U.S. response to a suspected biological attack; (2) strengthening the process through which microbial forensic evidence is created is just as important, if not more, than strengthening the science; (3) credible science needs a credible messenger, and credibility is fragile on politically sensitive issues such as those involving the prospect of terrorism; (4) advanced engagement of international partners can help mitigate natural, and politically expedient, tendencies to disregard or devalue scientific information that presents inconvenient truths to public officials abroad; and (5) the high probative weight that the United States affords to scientific evidence does not necessarily translate into other political or legal contexts abroad.

1. This article is an excerpt taken from Microbial Forensic Attribution: Where Science Meets International Relations, published by Christopher A. Bidwell and Mark Jansson on March 31, 2014. Mark Jansson was formerly an Adjunct Fellow for Special Projects at the Federation of American Scientists.

The full report can be viewed here. 

Op-Ed – Science Needs for Microbial Forensics: Developing Initial International Research Priorities

Committee on Science Needs Microbial Forensics: Developing an Initial International Roadmap, Board on Life Sciences, Division of Earth and Life Sciences, National Research Council of the National Academies.

Today we find ourselves with a complex infrastructure of government agencies, Select Agent registries, regulated research, environmental monitoring in designated cities, federal and state regulations—all resulting from one more or less successful biological attack on the United States. The Amerithrax attack with highly refined material produced by a knowledgeable expert (presumably in a U.S. bioweapons laboratory) resulted in 22 illnesses and 5 deaths. Approximately 4 g of material were used in the Amerithrax attack. At that time, the United States planned and prepared as best it could for an attack involving 50 kg of weaponized anthrax spores released on a city with a population of 500,000, anticipating 125,000 casualties. However, it is unlikely that a nonstate entity would be able to produce that quality or quantity of material undetected. Moreover, aside from B. anthracis, there are few (if any) biological agents that can be grown in quantity, viably maintained, stabilized, processed to the appropriate size, and delivered in an aerosolizable form except by a few specialized bioweapons facilities and certainly not by terrorists in a garage or cave. Most exotic microorganisms are just too difficult to grow and keep alive, even in the most sophisticated facility. In addition, the technology involved in weaponizing biological materials is complex, demanding, and requires substantial expertise. The more likely scenario is someone having access to a small amount of unrefined material that he/she uses to make a few individuals ill (causing perhaps a few deaths), the consequence of which will be a nation paralyzed with fear, not illness.

In that context, microbial forensics becomes more important than ever. How does one differentiate a natural outbreak from an accidental release from a legitimate laboratory, or the use of biological material to commit a crime, bioterrorism, and all-out biological warfare? How can this be accomplished quickly enough to inform law enforcement, the intelligence community, policy makers, and the public in a timely fashion? The traditional clinical laboratory sciences of culture identification, serology, etc. are inadequate for these purposes. It was with this background that the workshop in Zagreb, Croatia, was held in October 2013 with the intent to identify the scientific challenges that must be met to improve the capability of microbial forensics to investigate suspected outbreaks and to provide evidence of sufficient quality to support responses, legal proceedings, and the development of government policies. The workshop also was designed to increase awareness of microbial forensics among the members of the larger international scientific communities and to engage these communities in the development of a plan on how to address scientific challenges.

One of the more important concepts discussed during the workshop was that the techniques of microbial forensics could aid not only law enforcement and policy makers, but also public health workers, in trying to identify the existence and source of natural outbreaks. Indeed, as we saw in the Amerithrax attack, the public health system will likely be the first to encounter and the first line of defense against a biological attack. Most infectious diseases develop gradually, with individual patients seeking medical care through their local health care providers. People vary in their susceptibility to infectious diseases, and subtle clues may signal an attack, such as an increase in frequency of a naturally occurring infectious disease, unusual seasonality, unexpected resistance to antimicrobials, or unusual age distribution. These features are likely to be recognized first in the public health arena, and the more common the tools and techniques are between law enforcement and public health, the more likely that a true attack will be identified early, perhaps in time to administer prophylactic antibiotics or vaccines or prevent a second release. Moreover, the further we get from an actual attack, the less inclined policy makers are to provide financial support for continuing the research necessary to prepare for an attack. As noted in the 2013 President’s Report for the Global Partnership Against the Spread of Weapons and Materials of Mass Destruction (U.K. Foreign and Commonwealth Office, 2013):

Many of the capabilities required for detecting and responding to the whole spectrum of natural, intentional, and man-made events are essentially the same. Systems and networks that might be created for rare events will atrophy through lack of use, whereas systems created for addressing natural, man-made and accidental outbreaks of infectious disease are likely to be used frequently. Relying on tools and systems that are compatible with both rare and common occurrences means that in an instance of a rare event, detection and response will not be delayed by lack of familiarity with the tools or systems of reporting.

This article is an excerpt from Science Needs for Microbial Forensics: Developing Initial International Research Priorities, published by the National Research Council of the National Academies. The full report can be viewed at the following link: http://www.nap.edu/catalog.php?record_id=18737 

Op-Ed – A Necessary Biopreparedness Priority: Strengthening the Medical Countermeasures Enterprise

England1 258-362

Christina England, Master’s Candidate, Security Policy, University of Maryland School of Public Policy; Intelligence Officer, United States Air Force

One of the weakest U.S. bioresponse capabilities is the U.S. medical countermeasure (MCM) enterprise. Few in the fields of public health or biodefense would be surprised to hear that the U.S. is unprepared to respond to a virus for which no medical countermeasures exist. Additionally, bioweapons made resistant to U.S. medical countermeasures would also be catastrophic. Though all seven of the U.S. bioresponse capabilities – detection and diagnosis, attribution, communication, MCM development, MCM dispensing, medical management, and environmental cleanup – are essential in addressing both naturally occurring disease and man-made outbreaks, current stockpiles of MCMs are not adequate for large-scale attacks nor attacks that utilize resistant or novel pathogens. The medical countermeasure enterprise consisting of the development and distribution of MCMs is a significant liability in the U.S. bioresponse process.

Medical countermeasures include both pharmaceutical interventions like vaccines and antimicrobials as well as non-pharmaceutical interventions like ventilators and personal protective equipment (PPE) that may be used to prevent, mitigate, or treat the adverse health effects of an intentional, accidental, or naturally occurring public health emergency. Project Bioshield, reauthorized in 2013 to allocate $2.8 billion to the Biomedical Advanced Research and Development Authority (BARDA) over the next five years to procure MCMs, guarantees that the government will buy a certain quantity of MCMs at a predetermined price. As of January 2013, the U.S. had purchased from seven different pharmaceutical companies eight MCMs for the Strategic National Stockpile that address anthrax, smallpox, botulinum toxin, and radiological threats. So long as current funding levels are maintained, which is unfortunately questionable, BARDA envisions the procurement of 12 additional MCMs over the next ten years.

Despite Project Bioshield having been spared from sequestration, a variety of issues still plague the MCM enterprise. Of all the components of the MCM enterprise, improvements still need to be made to the HHS’ Public Health Emergency Medical Countermeasures Enterprise in its structure, priorities, and funding; MCM production in its contracting and regulatory processes; and MCM dispensing in its timeliness, logistics, and points of dispensing. It is the problems in these particular areas that, if not altered, can pose the most serious liability to U.S. MCM biopreparedness. While the current MCM enterprise led by HHS has taken extraordinary steps in manufacturing valuable vaccines, there are a multitude of diseases that still do not have a countermeasure. Also, if a pandemic were to strike, the ability of all levels of government to dispense countermeasures to the public in a timely, orderly fashion is questionable. By adopting measures that enhance the medical countermeasure production and distribution capabilities, thousands of lives could be saved in the case of a large-scale biological event.

 

1. This article is based on research carried out while with the Federation of American Scientists. For a more in-depth look at the challenges facing the medical countermeasures enterprise, see: Christina England, “The United States Medical Countermeasure Enterprise: A Broken Link in US Biopreparedness,” Journal of Homeland Security and Emergency Management, Volume 0, Issue 0, Pages 1–14, ISSN (Online) 1547-7355, ISSN (Print) 2194-6361, DOI: 10.1515/jhsem-2013-0043, January 2014.

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