10.6092/issn.2038-3460/17511
application/pdf
2038-3460
17511
2
en
Veronica Moretti
https://creativecommons.org/licenses/by-nc-sa/2.5/
Tecnoscienza – Italian Journal of Science & Technology Studies
off-label
Managing Uncertainty in Biomedical Innovation from Below. Exploring Tensions and Contradictions in Oncology and Pregnancy Cases
Text.Serial.Journal
https://tecnoscienza.unibo.it/
12
Conference Reflections
2022-03-26
2023-06-28
2022-03-26
2023-10-23
49-60
TS
Veronica Moretti
2021
10.6092/issn.2038-3460/17511
49
University of Bologna
2038-3460
2
off-label
en
60
Managing Uncertainty in Biomedical Innovation from Below. Exploring Tensions and Contradictions in Oncology and Pregnancy Cases
https://tecnoscienza.unibo.it/article/download/17511/16355
12
                                                             Conference Reflections
                                                                                      49




Managing Uncertainty in Biomedical
Innovation from Below
Exploring Tensions and Contradictions in Oncology
and Pregnancy Cases*

        Barbara Morsello                                   Veronica Moretti
              University of Padua                            University of Bologna



     Abstract: The contribution originates from Track 1, “Genetics and bio-
     medical innovation: Between risky and promising scenarios”, held within
     the VIII STS Italia conference. The session was intended to promote
     reflection on the implications of the latest innovations in genetic research
     and molecular biology for the formation of new care practices, as well as
     new surveillance and risk management. The objective of the paper is to
     highlights the contradictions and ambivalence that may rise from
     biomedical innovation through analysing two specific cases: 1) off-label
     practice in the context of rare disease in oncology and 2) pre-natal
     screening technology and surveillance practices. In both cases, these
     biomedical innovations, although very promising, produced high
     uncertainty, and the technologies and/or processes developed to cope with
     the ‘unknown’ were challenging. However, at the same time, tensions and
     contradictions were observed that originated unexpected practices ‘from
     below’. In particular, the following section is focused on the ambivalence
     that has increasingly taken root in the management of risks related to
     health with respect to individual contributions and to research and
     scientific work practices.

     Keywords: Biomedical research; genomics; digital pregnancy; self-
     surveillance; off-label.

     Submitted: October 20, 2021 – Accepted: December 30, 2021

     Corresponding author: Barbara Morsello, Biomedical Science
     Department, via Ugo Bassi 58/B, 35131, Padova, Italy. Email:
     barbara.morsello@unipd.it.




TECNOSCIENZA
Italian Journal of Science and Technology Studies
12 (2) pp. 49-60 - ISSN 2038-3460
www.tecnoscienza.net                                2019
50                                                         Tecnoscienza – 12 (2)

1. Introduction

    The session “Genetics and biomedical innovation: Between risky and
promising scenarios” was held in Trieste, Italy, at the VIII STS Italia Con-
ference “Dis/entangling technoscience, vulnerability, responsibility and
justice”, and focused on the rise of new practices related to biomedical in-
novation. New screening techniques are profoundly related to emerging
knowledge that shapes patients’ experiences. Furthermore, reconfigura-
tions of the infrastructures of biomedical innovation have also led to new
practices. The common thread in this development is the management of
some health-related risks, ranging from top-down forms of regulation and
surveillance, traditionally realised under medical dominance, to the recent
‘from below’ forms of participation in clinical practices, usually expressed
by the self-determination of and self-surveillance by patients. The
following paragraphs aim to explore numerous different gazes (medical,
patients and digital) in the identification and mitigation of some health-
related risks, sharing the perspective that even healthy situations can be
treated as pathological.
    Highlighting the role of human and non-human actors in the recon-
figuration of knowledge produced by innovation, the present contribution
reflects on two specific cases in which the ambivalences of risk mana-
gement by laypeople and clinicians were addressed.
    Specifically, the first case study concerned how biomedical innovation
is shaped by risk management in the clinical context and biomedical re-
search. As emerged during the conference, the tension between ‘adven-
turism’ and ‘securitism’ is particularly visible in the case of oncogenetics
and rare diseases, a highly experimental context, where protocols and off-
label drugs play a specific role in fostering (or not) innovation. Protocols
are conceived as infrastructures that – in certain contexts – must be re-
assessed, as in the case the prescription of off-label drugs that seems to
favour a ‘wild’ de-regulation process.
    The second case addressed new surveillance practices in the pregnancy
arena, ranging from screening technologies to online foetus visualisation.
This topic was examined to illustrate how pregnancy and birth have been
included in the process of self-surveillance and data-sharing. Risk
management in the everyday lives of pregnant women continues to use
traditional screening practices, but also utilise the ability of subjects to
negotiate this type of knowledge in public arenas such as social networks.
The medicalisation of pregnancy and birth helps in understanding the
surveillance of daily risks faced by pregnant women. Finally, as a conse-
quence of extended medical surveillance, research dedicated to lay strate-
gies towards risks suggests that the possibilities of sharing online ultra-
Morsello and Moretti                                                      51
sound images of the baby-to-be should be critically analysed among
scholars.


2. Dis/entangling Biomedical Innovation in Oncology:
Between Boundary Infrastructure and Therapeutic
Anarchism

    This section focuses on the tension between protocols, understood as
boundary infrastructures, and off-label clinical practices with the aim of
reflecting on ‘bioclinical adventurism’ as a resource for biomedical inno-
vation, as well as the deep limitations of this approach. Biomedical research
is a prolific field of experimentation; thanks to the greater availability of
information and new diagnostic biotechnology, a radical evolution in
patient care is underway. Predictive medicine, neo-adjuvant therapies,
which have recently become widespread in major health institutions,
convert a patient’s body into a theatre of medical-scientific experimenta-
tion, opening new possibilities of care.
    The field of precision medicine seems to be a promising way for di-
scovering correlations between DNA mutations and the risk of developing
different diseases, helping patients to acquire new practice of self-care and
illness-identity, perhaps simultaneously establishing a new regime of proto-
illness (Gillespie 2015). Moreover, screening, self-diagnosis, and predictive
tests are just some of the practices and tools now employed to gain greater
control over disease (Timmermans and Buchbinder 2010). As in the case
of genetics, the rise of knowledge acquired by biomedical research and
translational medicine have modified and shaped both the experiences of
patients and scientific and clinical practices. Genetic screening was
envisioned to identify risk factors by creating new bio-clinical entities
(Keating and Cambrosio 2003), and such diagnostic approaches are
essentially focused on prevention and managing uncertainty. Oncology is a
field of great experimentation with new techniques and care practices,
involving knowledge from molecular biology, genomics, and informatics,
as well as innovating diagnoses and stadiation processes (Huber et al.
2018). Thus, the production of biomedical knowledge concerning the
cytogenetic characteristics of the disease and medical treatments is no
longer confined to scientific laboratories (Martin et al. 2008; Cox and
Webster 2013) but is strongly connected to clinical practice (Crabu 2014;
Cambrosio et al. 2018). In line with this, oncology is an assemblage of
practices and knowledge where specific ‘oncopolicy’ may rise to norm
clinical and research activities that are also designated to reshape health
policy.
52                                                            Tecnoscienza – 12 (2)

    Looking at pharma for cancer treatments, drugs have very long and
complex trials where data are sources of legitimacy about off-label use,
Pascale Bourret (Aix-Marseille University), Alberto Cambrosio (McGill
University, Montreal), Jonah Campbell (McGill University, Montreal),
Peter Keating (University of Quebec at Montreal) and Jessica Polk (McGill
University, Montreal) underlined how physicians play a pivotal role in con-
structing the legitimacy of off-label uses instead of pharma companies or
researchers. Overcoming data legitimacy by physicians imply to reconfi-
gure authority of the data, by posing clinical experience with patient on a
new light and this may lead to what the authors call ‘therapeutic anarchy’
or ‘therapeutic adventurism.’
    However, several studies have documented the proactive and critical
engagement of patient associations in therapeutic and biomedical research
in various contexts as a solution to patients’ exclusion from health systems
(Epstein, 1996; Rabeharisoa and Callon 1999; Panofsky 2011). Notably,
patient associations are interlinking the rareness of diseases, the ‘politics of
numbers,’ and patient’s involvement in research (Rabeharisoa et al. 2014),
playing leading roles in the legitimisation of new care practices.
    A striking example of this is ‘off-label’ treatment. Off-label is defined
as the use in clinical practice of drugs or treatments that have already been
registered but are used in a way that does not comply with the requirements
of the authorised product. The drugs used off-label often include already
known molecules that are used in clinical situations for purposes not
explicitly approved from a regulatory point of view. This practice is
widespread in various areas of medicine where off-label prescriptions make
up a conspicuous proportion of prescriptions. The off-label prescription of
drugs is therefore allowed and regulated in some cases, even if not
explicitly approved, representing an important opportunity that could lead
to significant advances in the knowledge and treatment of certain diseases
as cancer. On the other hand, the off-label use of drugs exposes patients to
potential risks, given that the efficacy and safety of these drugs have been
evaluated in populations other than those being prescribed. In contrast,
patient organisations argue that such ‘exceptional’ programs should be
thought of and eventually redesigned as appropriate insofar as they bring
in ‘real-life’-based evidence on the clinical efficacy of the orphan molecules
and on their medical and social values. Indeed, the ‘off-label law,’ from the
patient’s perspective, take debates out of the strict realm of economic
evaluation to issues of unmet medical needs, accessibility, and social
justice.
    In France, for example, rare disease patient organisations have pushed
for RTU (temporary recommendation for use) as an appropriate option for
orphan drugs. They argue that there are numerous molecules that have
Morsello and Moretti                                                         53
already passed a series of toxicity tests that could thus be used for rare
diseases if they have shown some ‘real life’ bio-clinical impact on certain
aspects of the diseases (Rabeharisoa and Doganova 2016).
    However, the wide diffusion of this practice has created new ‘alliances’
between clinic, laboratory, and pharma. The wide availability of per-
sonalised drugs from molecular profiling services – public and private –
means that physicians can provide highly personalised off-label treatments.
Nevertheless, many of these drugs are introduced with very little
information about their effects. This is often the case for cancer treatments,
which are becoming increasingly precise and targeted, but there is also
poor bioclinical evidence of their efficacy. Finally, failures and successes
are not routinely detected when off-label drugs are prescribed. In this
regard, it can be problematised if off-label is the only suitable alternative
to produce innovation within highly experimental settings and to overcome
the stiffness of biomedical protocols.
    On the one hand, off-label use can be interpreted as a break in the in-
frastructural assumptions enshrined in protocols that could be interpreted
as boundary infrastructures (Mongili and Pellegrino 2014). Repositioning
off-labels in the context of rare diseases transforms treatments and care
practices, disentangling patients from protocols giving them more agency
about their conditions and experimental treatments.
    Rare diseases, in fact, are settings where knowledge is not sufficient to
implement new treatment, and therefore protocols are rigid and there is
difficulty in producing innovation. This situation takes on the features of a
paradox. In keeping with this, off-labels can be perceived as a source of
innovation and the way for patients with rare diseases to ‘break’ the infra-
structure.
    As remarked by Giuseppina Pellegrino (University of Calabria) in our
track, protocols are more than boundary objects. As pointed out by Star
and Ruhleder (1996), infrastructures are based on specific relational eco-
logies and are built around particular works and social practices. Assuming
this perspective, protocols become a relational concept, the generator of a
set of heterogeneous techno-scientific contexts where data can be
produced by all actors involved in clinical settings. Indeed, today we are
data citizens and our data are an integral part of our lives, especially related
to health and wellbeing. In this vein, the need to explain natural phe-
nomena in formal terms – to make knowledge available to the relevant
scientific community and actionable to laypeople – reveals a strong tension
between local knowledge, tacit knowledge (Collins 2010), and public
knowledge (Knorr-Cetina 1981). This is also because knowledge and in-
novative practices in biomedicine are increasingly interconnected between
clinical practice and scientific research following the model ‘from bench to
54                                                             Tecnoscienza – 12 (2)

bed’ (Neresini and Viteritti 2014), where patients are simultaneously
sources of knowledge and fields of experimentation. The tension between
protocols and off-labels in producing biomedical innovation indicates a
gap between aspiring to a highly desirable future, in which many serious
illnesses will finally have a cure, and the daily organisation of clinical
practice and laboratories. The collective dimension of biomedicine shows
some limitations, while it also reveals hidden asymmetries and deep
inequalities in the so-called post genomic and proto-illness era.


3. From Pre-natal Screening to Digital Foetus: The
Surveillance Course Perspective

     The main objective of this section is framing modern surveillance
practices as they apply to risk management in the pregnancy arena. More
broadly, considering the genomic turn of biomedicine addressed in the
previous section, being ‘at risk’, as a new social condition, presupposes the
control of individuals through screening practices that can estimate, in
numerical terms and through statistical modelling, the chances of getting sick
or, in the case of pregnancy, to prevent diseases for foetuses. Over time, as
claimed by Foucault (1963), the evolution of clinical practice, as well as the
growing development of new technologies, have brought about a change in
what is observed, what is found under the microscope of medicine, shifting
from a surveillance of symptoms to a surveillance of illness and to the
lifestyles of the subjects. Unable to trace a radical clinical distinction between
healthy and sick, everyone, according to Armstrong (1995), must be placed
in a surveillance network. This Shakespearean limbo produced by the
medical surveillance of risks generates a subject suspended between ‘to be ill
or not to be ill’ that has redesigned the boundaries and interests of medicine
and, above all, of surveillance. This extension to medical surveillance has
been applied to gestation over the years.
     Nowadays, in what has been defined as a post-genomic society, risk
anticipation surrounding pregnancy has become increasingly pervasive,
including not only recommendations on appropriate lifestyles regarding
smoking, alcohol intake, and food, but also medical technologies, invasive
screening, and numerous genetic tests, thus shaping motherhood. This is
interrelated to the concept of intensive mothering (Reich 2018), namely the
idea of mothers as able to prevent risks, pursue success, and manage their
(future) children’s health.
     Following Armstrong’s (1995) assumption, pregnancy is situated today
in an intermediate space between health (normal pregnancy) and disease
(pathological pregnancy) (Burton-Jeangros 2004), meaning that mothers-to-
Morsello and Moretti                                                          55
be must control and regulate every single aspect of their pregnancy pathways.
If being at risk is often interpreted as a predictor of future disease (Gillespie
2015), we should mitigate the uncertainty (Giddens 1991) through risk
anticipation. On the basis of Crawford’s definition (1980), healthism is
defined as ‘the preoccupation with personal health as a primary – often the
primary – focus for the definition and achievement of well-being; a goal
which is to be attained primarily through the modification of lifestyles’ (p.
368). In the pregnancy arena, a dominant view considers the foetus’s health
of higher importance than the pregnant woman’s health and well-being, and
this hierarchy makes ‘maternal sacrifice’ legitimate (Bessett 2010).
    The development of new technologies in reproductive health has opened
new opportunities for prenatal diagnosis and, at the same time, have
contributed to the medicalisation of the prenatal period with the
‘normalisation’ of prenatal foetal screening (Ettorre 2007). This is in line with
the prolific experimentation in biomedical research, as highlighted in the first
section. Various studies on the technical surveillance of pregnancy and birth
have described future ‘mothers’ contrasting experiences and expectations
regarding risk management surrounding prenatal screening and delivery’
(Burton-Jeangros 2004 p. 420). As highlighted by Alice Scavarda (Univer-
sity of Turin) prenatal screening is often intended to function to facilitate
selective abortion in case the foetus presents some abnormalities. Therefore,
parents who refuse prenatal testing or choose to carry the pregnancy even in
presence of a defect or a genetic disorder are deemed responsible for the
birth of their disabled child. Motherhood thus becomes a perfect target for
medical surveillance and actions taken to define legitimate and illegitimate
maternal practices (Ehrenreich and English 1978; Murphy 2003).
    On another level, recent developments in mobile technologies are
making this practice more user-oriented, as different channels (apps, sensors,
and social media) offer new ways of monitoring and measuring the human
body and the maternal experience (Lupton 2012). As reported by Adams
and Niezen (2015), identifying risk fits the paradigms of individualised and
personalised health, where health risks are considered to be manageable and
controllable via self-monitoring and self-care.
    Surveillance practices and the management of new biomedical risks can
be considered an integral part of our ordinary pregnancy routines. They are
becoming an everyday activity, routinely performed. In addition, the rapid
growth of self-surveillance pregnancy apps raises critical questions about the
commodification and surveillance of personal data (Barassi 2015). Based on
these premises, it can be argued that the use of the Internet and social net-
working to present the prenatal experience acts on two different fronts. On
the one hand, it encourages what has been defined by Andrejevic (2005) as
‘lateral surveillance,’ which concerns peer-to-peer monitoring and the use of
56                                                           Tecnoscienza – 12 (2)

surveillance tools by individuals rather than public or private institutions.
This form of horizontal control, exercised among peers, is particularly
widespread in the pregnancy experience. It involves subjects’ (mostly
voluntary) self-exposure on the internet and concerns three forms of
routinised social monitoring and self-expression, which are integrated into
the technological architecture of many contemporary social media platforms:
(1) watching and judging (morally, aesthetically, etc.) networked Others; (2)
watching Others watching oneself – that is, sensing and anticipating the gaze
of strangers as well as of fellow group members; and (3) watching one’s own
data double – that is, the hypermediated Self in the form of (for instance)
geographical positioning or personalised publicity offers (Christensen and
Jansson 2015, p. 1480).
    However, the representation of pregnancy in the online sphere also acts
on a second level. Following Oviatt and Reich’s (2019) work, posting status
updates, pictures, and events of the prenatal experience could help one to
make decisions regarding pregnancy and/or parenting. Already in 2010,
Rideout, Foehr, and Roberts presented how groups and channels for
prenatal and postnatal periods that appeared to provide visual and textual
information about pregnancy, parenting, social support, and humour were
popular among future parents, considering the different levels of expertise,
community networks, and of course cultural understandings. This constant
sharing of the future parenthood experience can impact the practices and
representations associated with pregnancy.
    Additionally, as Ilenia Picardi (Federico II University of Naples), Sole
Alba Zollo (Federico II University of Naples) highlighted during the
conference, the dissemination of foetal images on the web through the
analysis of a corpus of pregnancy websites/blogs/social media range from
weekly development guides to personal birth stories. As a result of the short
circuit of the use of the new diagnostic technologies and new communication
practices on the Web, pregnant bodies, conceived in the field of biomedical
diagnostics as the site of control of pregnancy, become the site for the social
construction of the digital foetus.
    The extensive sharing of foetal images by parents has enabled a situation
whereby corporations have access to important data regarding the unborn.
The datafication of the body and this new form of ‘foetus-veillance’ blurs the
boundary between private and public control. Some research (Barassi 2015;
Lupton and Pedersen 2016; Ley 2016) has shown that some mothers not only
endorse medical definitions of health risks but are also particularly eager to
share images and data of the unborn. This creates a digital environment in
which participation is often incentivised, and a variety of information is in-
creasingly commercialised.
Morsello and Moretti                                                        57
    We do not know whether such data will be lost in the digital ecosystem
or whether it will be integrated with other data, effectively impacting
children’s digital profiles and fuelling other surveillance practices. However,
we know that ‘data policies do not address this problem and collect
children’s data by relying on an ambiguous discourse that directs the
responsibility, once again, to users’ (Barassi 2017, p. 6). Quoting a famous
song by the Rolling Stones, “Fingerprint File”: ‘Keep on the lookout /
Electric eyes / Rats on the sell out / Who gonna testify / You know my habits,
way ahead of time / Listening to me, on your satellite.’


4. Conclusion

    Population screening, self-diagnosis, and predictive tests are just some of
the practices and tools now employed to gain greater control over the
development of disease, reinforcing the intersection between health, risk,
and technology. As Jasanoff (2003) pointed out, risk is part of the modern
human condition, woven into the very fabric of progress.
    The present contribution proposes a reflection on the tension between
new forms of negotiation and participation in biomedical research. Patients’
participation in the processes of biomedical innovation is multifaceted; they
are both the subjects of clinical experimentation and the sources of genomic
data in diverse fields, from oncology to neurodegenerative, metabolic, and
cardiovascular diseases. But individual forms of participation as biomedical
innovation are also located in other fields, such as pregnancy. Risk manage-
ment is particularly encouraged in pregnant women, where their everyday
lives represent a central feature of the experience of pregnancy.
    Through self-surveillance, pregnant peoples’ bodies cease to be objects
of medical knowledge and become a mode of knowing (Mol and Law 2004).
Collecting data about different conditions could increase the set of know-
ledge and know-how showed by mothers-to-be. Conversely, in highly experi-
mental settings, technological innovation produces new forms of knowledge,
as in the case of oncogenetics; however, at the same time, it can become chal-
lenging to translate innovation into stable clinical practices. While protocols
act as patient safety devices, in the case of rare diseases, they become highly
constraining infrastructures for innovation. This tension can lead to the
emergence of borderline practices, such as off-label treatment prescription,
presenting scenarios that are potentially harbingers of innovation but where
the risks of therapeutic adventurism are still poorly under-stood.
58                                                                 Tecnoscienza – 12 (2)

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    *
      While this article is the result of several discussions between the authors,
Barbara Morsello has written sections 1. “Introduction” and 2. “Dis/entangling
biomedical innovation in oncology, between boundary infrastructure and
therapeutic anarchism” and Veronica Moretti has written sections 3. “From
prenatal screening to digital foetus: The surveillance course perspective” and 4.
“Conclusion”.
