The governance of biological emergencies has been an important issue during the last
decade. Much policy work has been done on the topic, aiming at covering the necessities
associated to bio-preparedness – ie, preparedness for biological threats. In this
context, there is a lot to be said and understood by looking at emerging biological
entities, such as new viruses or bacteria. Some of the most important international
organizations worry about this issue: The North Atlantic Treaty Organization (NATO),
World Health Organization (WHO), or European Union (EU) have specific sections specialized
in dealing with this matter. Such concern has been fed by the expert opinion asserting
that a big pandemic is imminent. This is based on several developments that have taken
place during the last decades: the 80s saw the expansion of Ebola and HIV, and the
90s and 2000s witnessed the appearance of the Creutzfeld-Jacob’s disease, severe acute
respiratory syndrome (SRAS), and different types of influenza viruses coming from
other species, such as the avian influenza or the H1N1. These outbreaks, together
with the Anthrax attacks that took place in the aftermath of 9/11 and the research
on genetic engineering of viruses has led to a general state of fear of biological
threats. Such events are characterized by a strong interaction between the social
and the biological, between populations and viruses. I suggest that conceptualizing
viruses as bio-objects will be helpful in our attempt to understand such interaction.
The bio-objects framework, which has been developed by the research network “Bio-objects
and their Boundaries: Governing Matters at the Intersection of Society, Science and
Politics” (1,2) has provided an interesting way of thinking about emerging biological
entities. A number of analyses with different biological entities have already been
reported in this same journal. MicroRNA’s (3), dried blood spots (4), genetically
modified insects (5), transgenic food (6), or HeLa cells (7) serve as examples. Such
variety of work shows the versatility of the concept. In an attempt to understand
the dynamic processes that give raise and regulate emerging biological entities, the
concept provides a theoretical and methodological tool useful to explore new fields
related to biology and life sciences.
In this article I will claim that the bio-objects framework is a useful tool to connect
some biological dimensions of biosecurity with the political and the social. The framework
is beneficial when we aim at tracking and following biological entities that are controversial
and subject to change. Controversies are common in the area of biosecurity, an area
that embraces institutional entities situated in the intersection of science, economy,
security, law, society, and politics. It is within this background that viruses need
to be understood nowadays: as objects that transgress existing boundaries and classifications
while their identity is continually challenged. They are, in that sense, suitable
to be understood as bio-objects. I will try to illustrate these ideas using a recent
controversy on the consequences of genetic engineering on Highly Pathogenic Avian
Influenza (HPAI) A/H5N1, a virus that appeared in 1997 in Southeast Asia and that
has been threatening to overcome the human/animal interface since then. By following
research articles, pieces of news and reports, I have carried out an exploratory analysis
that intends to understand viruses as immersed in a bio-objectification process.
Social research on biosecurity
Three different sources are considered by biosecurity policymakers: a) natural outbreaks,
b) bioterrorism, and c) laboratory accidents. What is interesting about this 3-fold
interaction is that the three of them incorporate disparate rationalities coming from
different sociopolitical practices. While natural outbreaks are usually a public health
issue, bioterrorist attacks are a civil defense and national security concern. The
former is in deep relation with medicine and epidemiology, the latter with military
forms of thought. This interaction is deeply related to United States (US) politics
where, during the last quarter of the 20th century, diseases that were approached
exclusively as medical issues became an issue for national security too (8). The third
rationality mentioned is the one of laboratory accidents, mainly represented by accidental
releases. This is regulated through biosafety rules, which are guided by the WHO,
leaving the responsibility scattered among scientists, research institutions, and
funding organizations. This third rationality interacts with the two previous ones
by incorporating a controversial dilemma: life sciences research entails threat and
progress in the same activity.
The interaction of these three rationalities is also a source of controversy in the
field of biosecurity as it integrates different institutions and disciplines that
have a common interest but that have historically had different objectives. The emergence
of an infectious agent in the population is handled through policies that fall under
the umbrella of biosecurity, a wide term that enrolls many institutions that work
in different political disciplines. This implicates that a given outbreak is understood
under the light of military, health, and research rationalities at the same time (Figure
The three sources of threat for biosecurity policies and their respective rationalities.
Policies pick up this biological threat and are developed discursively in a state
of uncertainty, risk, threat, and fear. These four ideas are in the core of any anticipation
of a biological emergency. In that state of alert, a biological event is expected
to happen, though we do not know when, where, or how. Threat and fear are instituted
as the new normality (9) and biosecurity scenarios (10) are the only way to evaluate
future events. This alert attitude needs to be maintained in order to be prepared
to act in front of an emergency. A constant state of uncertainty brings in deep difficulties
for governance processes. As future happenings are uncertain, effective policymaking
becomes an extremely difficult task, if possible at all. In cases of sociotechnical
controversy, the higher the stakes are, the less certainty is allowed (11). As the
consequences of a biological event are hardly predictable but usually categorized
as “devastating,” some experts and policymakers feel the need of preparing for any
possibility, no matter what the probabilities of the event may be.
Under the effect of such discourses, biosecurity policies enter the field of bio-preparedness.
In front of an unknown threat they adopt the perspective of what is called an “all
hazards approach.” Countries need to get themselves ready for any kind of possible
threat. Calculations and probabilities seem to be left out here: a distant possibility,
because of its potential effect, is taken as a very close one. In this context, the
logics of biosecurity move from prevention to precaution and to preparedness (12).
The first one, prevention, linked to veterinary practices, relies on data of prevalence
and incidence: it is a rationality of cases and propagation zones and knowing the
enemy means being able to fight it. Precaution, on the other hand, pays attention
to the limitations of knowledge. In such a case, the possibility of a trustable prediction
is put in doubt, opening space for public deliberation. Finally, preparedness blurs
knowledge and focuses directly on the potential consequences of an event. It is not
that the new rationality erases the previous one, but it limits its sphere of application.
The lack of knowledge in preparedness is dealt through scenario development and simulation,
where fiction and reality meet (13). As fiction easily tends to overcome reality,
the influence of fiction-based risk assessment is much more profound than knowledge-based
risk assessment. Hence, policies and funding seem to shift their interest more toward
preparedness than toward prevention.
Preparedness policies are built in a context characterized by the on-the-making processes
that flood biosecurity controversies and are characterized by constant development.
They are deeply rooted in the idea that preparedness is continuous (13); it is not
seen as a final objective but as an ongoing process that can hardly be closed down.
As these features are part of the most basic ideas laid down under such policies,
they deploy what I call “standby policies.” These policies are designed to cover future
events but they cannot be implemented unless such events happen. They are developed
in a symbolic hypothetical context. Still, they have an actual effect in life governance
while their formulation remains virtual (14).
Such discourses give meaning to the current state of affairs of research on emerging
infectious diseases (EIDs). The controversy analyzed here cannot be understood as
an isolated case, but as a consequence of decades of political, social, and scientific
The mutant flu controversy (15,16)
In September 2011, Ron Fouchier and his team, from the Erasmus Medical Center in the
Netherlands, reported at the European Scientific Working Group on Influenza’s conference
in Malta having pushed certain mutations in the long time known A/H5N1 Influenza virus.
These mutations made the virus able to be transmitted among ferrets, the most used
animal model in human Influenza research. Concurrently, Yoshihiro Kawaoka, who runs
two biolaboratories, one at the University of Wisconsin-Madison and another one at
the University of Tokyo, carried out similar research with similar conclusions. Both
researches were funded by the US government. Papers reporting on the results were
sent to leading journals: Fouchier’s to Science and Kawaoka’s to Nature. But before
publication, the National Science Advisory Board for Biosecurity (NSABB), the US institution
competent in the matter, reviewed both papers to evaluate their implications related
to dual-use research concerns. The papers were evaluated during October 2011 and a
decision was made public in December: the papers would be published with redaction
of the methodological design in order to avoid potential misuse of the mutant virus.
Access to all the details of the research would be provided to certain authorized
researchers. The publication was scheduled to take place during March 2012. As part
of the controversy, a 60-day moratorium on HPAI H5N1 research was declared on January
2012, which finally lasted more than one year, until February 2013. The objective
of such moratorium was “to provide time to explain the public health benefits of this
work, to describe the measures in place to minimize possible risks, and to enable
organizations and governments around the world to review their policies” (17). During
that time, in February 2012, a new meeting between WHO and NSABB members took place.
The result of such meeting was that both papers needed to be published fully. The
arguments that led to this decision were the need to stimulate public health research
and the difficulty on deciding who would and would not have access to the non-redacted
material. A final meeting between the NSABB and the authors took place in March 2012
in order to revise the final drafts. At last, by June 22, 2012, both papers had been
The controversy was mainly fed by the discussion on the potential risks and benefits
of H5N1 gain-of-function research. So, the first questions asked were related to how
dangerous or beneficial the research actually was. On the one hand, the ability to
make H5N1 transmissible in mammals could be used by bioterrorists and the fail of
biosafety techniques could provoke an accidental release of the virus. On the other
hand, knowing how the virus might develop can help to assess the threat posed by viruses
sampled from wild or farm animals and human confirmed cases. Another source of problems
that fed the controversy was the legal and political framework that surrounded it.
US law did not allow redacting the research partly: it had to be published fully or
classified. Also, politically, it raised problems at the international level. The
Pandemic Influenza Preparedness (PIP) Framework, run by the WHO, is a program that
engages many countries and it is considered a basic tool for Influenza preparedness.
Not sharing this information with the rest of the members of the PIP could be seen
as problematic, motivating some countries to fall off the program (as Indonesia had
done in front of another polemical situation regarding the fabrication of Influenza
vaccines in 2006) (20).
The controversy was solved/silenced thanks to the final decision about how the research
articles should be published. But consequences were to follow. US carried out policy
changes that now allow government officers to review and monitor biological research
implicating any pathogen present on the list of 15 biological entities of potential
dual-use concern. US government is also allowed, under such policy changes, to modify
the methodological design and the conduct of US funded research.
The A/H5N1 Influenza virus as a bio-object: the bio-objectification process
The A/H5N1 Influenza was first detected among humans in 1997. Since then, the virus
has been identified as causing zoonotic disease. In the period from the beginning
of 2003 to October 8, 2013, 641 laboratory cases were reported to the WHO, 380 of
them being lethal (21). H5N1 has been a pandemic threat for about 16 years now. Its
stability as an object has been subjected to the emergence of new mutations, to peaks
in its contagiousness on humans or animals, and to public controversies. The so-called
“mutant flu” controversy has been one of those moments when stability becomes compromised
and the bio-objectification process becomes visible and suitable to be analyzed.
As we take a closer look to the experiments carried out by Fouchier and Kawaoka, the
identity held by A/H5N1 is already fragmented as different samples need to be separately
identified. For example, Fouchier experimented with the virus A/Indonesia/5/2005 and
Kawaoka with the A/Vietnam/1203/2004. These names serve already as identifier that
stabilizes the sample (22), as an object susceptible of being collected, stored, and
shipped. Being the samples already linked to the time and place of their collection,
mutation in the laboratory implicates a new identity already: the virus result of
biotechnological labor will differ from the original sample. We need to also acknowledge
that such identities are not equally relevant for everyone: such fragmentation of
the main H5N1 identity is relevant for experts but not entirely for other milieus.
For example, most journalists, lay people, and politicians will keep referring to
the virus using the name H5N1.
The bio-objectification process starts to be evident inside the controversy as the
sample is transported from a biobank in Hong Kong to a biolaboratory in Amsterdam,
in the case of Fouchier, and from Vietnam to the US, in the case of Kawaoka. After
such process, biotechnological labor is carried out. Both samples are submitted to
modifications in order to potentiate their capability to be transmitted among mammals.
In the case of Fouchier, by genetically modifying the virus using site-directed mutagenesis
and subsequent serial passage in ferrets, the virus was able to be transmitted among
ferrets. Furthermore, such material changes also affected the pathogenicity of the
virus. Besides the ability of transmission, the fatality was drastically reduced and
none of the recipient ferrets died after airborne infection with the mutant A/H5N1
viruses. In the case of Kawaoka, the team identified a reassortant H5 HA/H1N1 virus.
This was a combination of H5N1 and an H1N1 sample from the 2009 pandemic influenza
outbreak. Such reassortant was capable of droplet transmission in a ferret model.
Kawaoka’s virus replicated successfully among ferrets but was not highly pathogenic
and did not cause mortality. The changes on their capacities are central to understand
the controversy. The previous point of concern for biosecurity was the high pathogenicity
of the A/H5N1 Influenza, and its ability to spread was the only thing keeping the
virus out from becoming a pandemic (although it was considered a pandemic threat).
Both mutated viruses incorporate the ability to be transmitted among humans (inferred
through an animal model), but lose its high pathogenicity. At this point, the materiality
and capacities of the virus have changed but its identity keeps being the same for
a big part of the society, including politicians and regulators.
Subsequently, regulation – a process inside the symbolic dimension of the bio-objectification
process – is required as the new capabilities and materiality do not totally fit with
the known identity of the virus. In this new regulatory activity, NSABB, WHO, and
the journals Science and Nature, as well as mass media, attributed a series of features
that will configure the identity of the object: mutant, deadly, or lethal are adjectives
that became attached to the new identity of the virus. Such process has been deeply
conditioned by the material changes but it is not until regulatory agents enter the
scene that the identity change starts to be evident, as the material change process
was when the samples started to move. Material change is situated in the material
dimension of the process, while identity change needs to be understood in the interface
between the material and the symbolic dimension (Figure 2). Both dimensions are inseparable
as they are necessarily intertwined, but they do not share actors, practices, and
spaces during the whole process. The final decision and regulation of the data related
to the new agent allows the controversy to be solved/silenced, conferring some stability
to the bio-object and its identity.
The bio-objectification process.
But what are the consequences of this process? How does society apprehend such changes?
The first interesting consequence of bio-objectification processes is the challenging
of existing classifications and boundaries. Laboratory/nature becomes a relevant dichotomy
for the configuration of the biological object. Through laboratory practices, nature
is anticipated. The previously uncertain event of a natural mutation of a H5N1 Influenza
virus is not only artificially predicted but also artificially enacted (the fictionalized
prediction of a pandemic is, in a way, voluntarily pursued). Species boundaries are
clearly another set of barriers that is challenged by the controversy. While the use
of animal models, such as ferrets, is nothing new in biological research, the genetic
engineering of the virus reminds us of the mobile barrier between epidemic, epizootic,
and zoonotic diseases. A third category of challenged boundaries is the one of disciplines.
As the controversy develops, the new virus enters, discursively, more and more disciplinary
areas. The challenges for the researcher are beyond microbiology. They need to answer
in front of the press, committees, boards, etc. The virus has entered the space of
politics, law, international relationships, and security.
A second interesting consequence of such modifications is that the values attached
to A/H5N1, as well as its own value as an object, are reevaluated. The potential identities
of the virus imply new forms of understanding it as a threat. While before it was
classified as a natural threat, now it is classified as a human-made threat – therefore
avoidable to some extent. Value creation is always in relation to the interactions
of the virus with other social actors. In the proper hands, the virus will acquire
the proper value – ie, a positive value. Researchers will use it for public health
benefit. In the wrong hands, it will acquire negative value as terrorists could use
it for nefarious purposes. But it is important to acknowledge the uncertainty of such
changes. The abilities to carry out genetic engineering are not so easy to learn and,
on the other hand, laboratory accidents are not only dependent on the good will of
researchers. So, whether the engineered virus will become a great opportunity to tackle
the pandemic influenza threat or a great threat for the entire humanity remains unknown.
This new potential value, still uncertain, feeds the rationality of preparedness.
Thinking of biological controversies in terms of bio-objectification allows us to
reflect on materiality and meaning as processes that, far from being stable, are constantly
on-the-making. The eventual and transitory stability of biological entities is always
linked to broader social processes that escape scientific practice. The attention
paid by the bio-objects framework to political and, more precisely, regulatory practices,
is crucial to understand the stabilization of bio-objects submitted to processes of
biotechnologization and their identification processes. Furthermore, the bio-objects
framework seems to be useful in order to analyze the most molecular dimensions of
biosecurity, having its starting point in the technical labor carried out in microbiology
laboratories. This way, it helps connecting the practical dimensions attached to the
practice of microbiology to the political dimensions attached to policymaking in biosecurity.