Two influenza studies created a firestorm last year before they were even published. The two studies presented findings on lab-modified strains of H5N1 influenza virus that showed signs of increased transmissibility in mammals. The studies’ eventual publication in Science and Nature followed months of debate on whether to communicate the findings and if so, how to communicate them appropriately while also protecting public health.
The debate was sparked by concerns from the National Science Advisory Board for Biosecurity, a federal advisory committee (of which I am a voting member) that was consulted during the review process. The episode raised important questions about how to anticipate, oversee and assess “dual use research of concern” (DURC) in the life sciences—research with a legitimate scientific purpose that could be directly misapplied to pose a threat to public health, agricultural crops and other plants, the environment or materiel.
As a professional society of physicians and scientists involved in a wide range of ID research, teaching, and clinical and public health work, IDSA is uniquely positioned to bring valuable perspectives to the table as the scientific communities, government, and the rest of the public continue to tackle these issues.
Why does this matter to the ID specialty? Although risks can come from any aspect of the life sciences research enterprise, ID specialists are especially likely to be engaged in research with dual use potential. This research can provide knowledge to help defend against naturally occurring pathogens, such as a highly transmissible strain of highly pathogenic avian influenza, or a deliberate act of bioterrorism. The work can help aid in the development of more effective drugs, vaccines, and diagnostics, and can contribute to surveillance efforts. Without appropriate oversight and safeguards, however, this research also carries the risk of accidental laboratory release of dangerous pathogens, as well as misuse of the information by irresponsible or malevolent individuals, groups, or nations. ID specialists are especially well-positioned to understand the risks and benefits of some of the more common forms of DURC, and hence to be valuable advisors for those who will need to undertake risk-benefit analyses.
The U.S. federal government, one of the largest funders of H5N1-related research in the world, has taken actions on several fronts during the past year. In March 2012, the Department of Health and Human Services (HHS) released a new government-wide policy (PDF) for overseeing DURC involving certain pathogens and toxins that is conducted or funded by the federal government. Federal officials are also developing guidance to help research institutions conduct DURC reviews locally.
In late 2012, HHS proposed a new draft framework (PDF) for decision-making by the government about whether to fund studies that alter key biological characteristics of highly pathogenic avian influenza viruses. Earlier this month, the voluntary moratorium on certain H5N1-related research, self-imposed by many influenza researchers during the debate about the Science and Nature studies, was lifted, pending finalized funding and biosafety policies by governments in each country, including the U.S.
This past fall, HHS also sought public input on whether H5N1 strains should be designated as “Tier 1” select agents, a new designation that requires additional security precautions for research, and whether they deserved biosafety measures beyond those already in place. IDSA made a distinction: The Society recommended that naturally occurring highly-pathogenic H5N1 viruses be regulated as select agents with current biosafety and biosecurity regulations, while H5N1 viruses that have been engineered for greater transmissibility or pathogenicity should be regulated as Tier 1 select agents, with increased biosafety and biosecurity restrictions. Of course, microbes don’t play by our rules; they are always evolving, so IDSA noted that the benefit-risk calculus is dynamic and should be re-evaluated as new strains arise naturally. (Read IDSA’s comments online [PDF]).
In monitoring this issue, IDSA has been guided by the need to strike the appropriate balance: If we impede this research, we might not gain the knowledge needed to help prevent or lessen the severity of a naturally occurring, dangerous outbreak. On the other hand, if we fail to put appropriate safeguards on this research, we risk an act of bioterrorism or an accidental release, with potentially catastrophic consequences.
The editors of IDSA’s journals are aware of these concerns and are addressing these issues on a case-by-case basis so that freedom of scientific expression can be promoted without sacrificing safety or national security.
These are complex and evolving issues, as are the pathogens and the broad areas of science involved, with few easy solutions. The recent controversy about engineered bird flu viruses should be viewed as a wake-up call about the growing risks that accompany the benefits from the ongoing life sciences revolution. As the professional medical society for the ID field, it is critical that IDSA not only participate in the discussion but take a proactive role as it moves forward. The implications for public health and welfare—here and around the world—are simply too great.
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