Case Study in Recombinant DNA Technology and Biosafety
By Michelle Hustedt and Laura Rivard
Introduction: Avian flu is back in the news. This time, the offending strain is known as H7N9. The last avian flu to make headlines was H5N1. This virus is highly pathogenic and has a 60% case fatality rate. To date, it has only been transmitted from bird to person, so relatively few people have been infected (approximately 600 in 15 countries since 2003). This is in contrast to the H1N1 "swine flu" pandemic of 2009, which was passed person-to-person, and infected tens of millions of people worldwide. However, the case fatality rate was only 0.01-0.03%, and very few infected people died. If H5N1 ever acquires mutations that allow for transmission between humans, the death toll will likely be catastrophic. Some scientists believe the best way to understand influenza strains like H5N1, and now H7N9, is to perform "gain-of-function" studies, which address viral characteristics like adaptation, pathogenicity, and drug resistance, in part by introducing random mutations. Included in these studies is the introduction of mutations that allow the virus to become transmissible in humans. Obviously these types of studies pose serious biosafety and bioterrorism threats. The following case study provides an overview of the controversy that surrounded publication of the H5N1 gain-of-function studies a few years ago. Since then, the US Department of Health and Human Services (HHS) has announced new guidelines for performing experiments with influenza viruses such as H5N1 and H7N9. However, many remain unconvinced that such studies are necessary at all, and the current H7N9 outbreak is likely to reignite the debate.
Case Study: In 2011, a group led by Dr. Ron Fouchier of the Erasmus Medical Center in the Netherlands used recombinant DNA technology to artificially introduce mutations in the H5N1 avian influenza virus that makes the virus easily transmissible from human to human. At present, the "bird flu" has only infected humans that are in direct contact with an animal host. However, there is a chance that the virus could naturally mutate into a form that will allow human-to-human transmission, leading to a pandemic. Thus, some scientists believe that it is important to study the genetics of H5N1 transmission in order to monitor for mutated strains in the wild and better prepare to treat outbreaks in the future. Dr. Fouchier and his colleagues discovered that only five mutations are necessary to allow for airborne transmission of the virus between ferrets (the model organism used to study viral transmission in humans).
Prior to publication, Dr. Fouchier presented his findings at a conference in September 2011. Concern arose immediately regarding the release of information on how to create deadly, transmissible viruses; were such experiments providing a "blueprint" for the creation of a new biological weapon? Additionally, were adequate biocontainment practices in place to ensure against the accidental release of the mutated viruses from the laboratory? In an unprecedented action, the National Science Advisory Board for Biosecurity (NSABB) asked the scientific journals that had agreed to publish the work to remove certain details from the papers. The NSABB cited a risk of bioterrorism when defending their decision. This resulted in a delay in the publication of the papers and a voluntary year-long moratorium on such research. Ultimately, however, in March 2012, the NSABB reversed their decision, and in June 2012 the papers were published in full. Though the NSABB reversed their original request, and the voluntary moratorium is over, the issue of creating deadly viruses is still controversial. The question remains: does the benefit of examining the pandemic potential of deadly flu viruses and bolstering early detection methods outweigh the risks of misuse of the information published from such studies or the threat of accidental release?
References:
Grady, Denise and Broad, Wiliam. “Seeing Terror Risk, U.S. Asks Journals to Cut Flu Study Facts”. The New York Times. December 20, 2011.
McNeil, Donald “Bird Flu Paper Is Published After Debate”.
Fouchier, Ron et al. . Avian flu: Gain-of-function experiments on H7N9. Nature 500, 150-151 (2013)
Image credit to the CDC (via Wikimedia Commons)
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It is certainly interesting to cover a topic that the scientific community is still quite divided on. More recent discussions have focused on biosafety concerns and less on the terrorism angle. Detractors have raised a point that speaks to Gary's comment: these avian flu outbreaks are happening in countries with limited public health resources. Even if we have the technical ability to detect new mutations in avian flu viruses in the wild that indicate a move toward human-to-human transmission, there are barriers to actually doing it.
I would love to hear from a scientist in this field to get an insider's view.
It seems to me that to conduct an accurate risk/benefit analysis one would have to have some concept of the likelihood of the natural evolution of a bird virus that was communicable from human to human. The prompt indicates that there is a "chance" that such natural mutation could take place. If the likelihood is very low, then I think that the issues of waste of resources and use for bioterrorism are more significant.
The concept of bioterrorism threat comes into play when the knowledge and its solutions are not transparentally shared universally for whatever reasons ascribed to it( call it fear,greed,profit and/or feeling of supermacy etc.).
Perhap's that how the human mind work's!.
Secracy/ restriction leads to active persuit!!
what's obvious hardly gets attention.!!!
The proper time to consider the validity of this kind of work is _before_ it's done. I think this research can be quite helpful, but effective oversight and regulation should be an important part of the process.
I'm not entirely convinced by the 'bioterrorism threat' angle. If the research is easy & inexpensive, then 'bioterrorists' don't need to wait for publications like this. If it's challenging & expensive, then it should be possible to monitor qualified people and track the necessary infrastructure and materials.
Perhaps my take is a bit naïve, but I'll put it out there in the hope of getting a discussion started! :)
