|T H E N I H C A T A L Y S T||M A Y J U N E 2008|
C O M M E N T A R Y
THE DUAL CHALLENGES PRESENTED BY DUAL-USE RESEARCH
This essay is intended to open a dialogue for a plan of action for evaluating dual-use research both before it is undertaken and before publication.
An investigator decides to develop a vaccine against a select toxin known for its resistance to conventional denaturing conditions. After purifying the toxin in the usual way, he adds a rather simple step and finds that on testing in mice, the oral LD50 is 0.1 percent that reported in the literature! (Lethal Dose 50 is the dose at which 50% of the animals die.)
This result, taken from a real occurrence, is a typical example of “dual-use research”—that is, research that may generate valuable scientific knowledge but that could also be deliberately used to create serious harm to the public health or the environment.
Whether the investigator should publish this finding is the dual challenge presented by dual-use research results. On the one hand, it is important to publicize the findings so that others can make use of the new knowledge to our mutual benefit; on the other hand, one wishes to avoid dissemination of information that could easily be used by someone to create havoc.
That advances in biotechnology require only relatively simple resources to be misused for destructive purposes has long been recognized, but the terrorist activities of September 11, 2001, and the deliberate dissemination of anthrax spores shortly thereafter magnified this concern within both the scientific community and the public at large.
A keyword search for “bioterrorism” within the PubMed database fails to yield a single hit before 1996, but in 2002, the peak year, almost 900 citations are listed. In parallel, potential dual-use research results such as those listed in Table 1 have appeared on the front pages and in op-eds of the nation’s most influential newspapers, and they have raised controversies about their publication in the halls of Congress.
Academies of science in the United States, the United Kingdom, and elsewhere have organized conferences on the subject; an in-depth monograph on the subject by the U.S. National Research Council (Biotechnology Research in an Age of Terrorism, 2004) has been particularly influential. Professional societies—in particular, the American Society for Microbiology and FASEB—have promoted discussions of the issues, and the U.S. government responded by creating a National Science Advisory Board on Biosecurity in 2004.
The Board’s membership includes representatives of government security agencies, health agencies—including, of course, the NIH—and academia and industry. Its “Proposed Framework for Oversight of Dual Use Life Science Research: Strategies for Minimizing the Potential Misuse of Research Information” was issued for public comment in June 2007. Special emphasis has been directed towards those areas of research that are of most obvious concern such as those listed in Table 2.
The importance of international co-operation for dealing with the challenge of dual-use research is self-evident. A second “Forum on Biosecurity (see agenda and PowerPoint presentations),” attended by 31 countries and sponsored by eight international organizations, was held March 31–April 2, 2008, in Budapest.
All those considering this subject have emphasized the foremost importance of educating members of the research community about the dual-use research dilemma, recognizing that, as with recombinant DNA research, the scientific community itself is in the best position to properly balance the advantages of open unfettered research and communication of its results and the need to protect the public from harm.
Table 3 lists the annual number of deaths from various causes over the five-year period from 2002 to 2006. It would be a tragedy if by self- or government-imposed censorship occasioned by the threat of misuse, research directed towards the biological, behavioral, and social factors responsible for the major causes of death and morbidity were to be constrained.
The best way to avoid that scenario is for the scientific community to provide credible evidence that it is willing and able to deal responsibly with the public’s legitimate concerns.
|Table 1. Recent Examples
Extending the host range of Listeria monocytogenes by rational protein design (human to mouse, 2007)
Comparison of immune response to a virulence gene from vaccinia and smallpox (2002)
Total synthesis of poliovirus genome (2002)
Enhanced virulence of mousepox virus–IL-4 construct (2001)
Table 2. Principal Types
Of Research Results
That Raise Dual-Use Concerns
Enhance the harmful consequences of a biological agent or toxin
Disrupt immunity or the effectiveness of an immunization without clinical and/or agricultural justification
Confer upon a biological agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate its ability to evade detection methodologies
Increase the stability, transmissibility, or ability to disseminate a biological agent or toxin
Alter the host range or tropism of a biological agent or toxin
Enhance the susceptibility of a host population
Generate a novel pathogenic agent or toxin or reconstitute an eradicated or extinct biological agent
Table 3. World Mortality Statistics
Communicable diseases and maternal, perinatal, and nutritional conditions
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