Introduction

In recent years patients have increasingly united and worked to assert their own interests in health research. This involvement has taken place in the context of patient organisations (henceforth POs) as contributors of ideas, funding, and suppliers of tissue and data, which has been framed as helping to ‘democratise’ science (Rabeharisoa 2003; Pinto et al. 2018). In this article we explore the positions of POs engaging with public sector researchers and life science companies to further medical research in biomarker and precision medicine in Denmark. We contribute to the discussion of the possible challenges and tensions such alliances might entail for POs by presenting a social arena analysis of the heterogenous discourses, images, and positions available to the various actors in the Danish case (Clarke and Montini 1993).

As part of a national effort to promote the development of precision medicine, networks that nurture collaboration across the public and private sector have been encouraged and supported in Denmark, with civil sector stakeholders also being invited to take part. Exemplifying this is the Danish National Strategy for Precision Medicine 2017–2020, which explicitly calls for patient centricity, thereby implicitly inviting a new kind of actor into the networks: patients and their organisations. However, engaging in such collaboration is not without complications for POs, whose independence in terms of commercial interests is commonly questioned when they collaborate with private actors in general and the life science industry in particular (McCoy et al. 2017; Mandeville et al. 2018). Substantial financial connections and the legitimacy of donations from the life science industry to POs have been problematised by researchers over the years as such alliances can cause moral disputes and potential conflicts of interest (Ozieranski et al. 2020). Due to such controversies, the nature of the relationship between POs, the life science industry, and public sector researchers is often underreported or silenced.

With this point of departure, this article raises the questions: What kind of relationships emerge as POs are invited into partnerships with researchers and the life science industry in the name of patient centricity? How do POs balance legitimacy, representation, and independence in such collaboration?

Background and context

This article addresses these questions based on data produced in the project ‘Biomarkers as an emerging growth area’—hereafter the biomarker project—funded for 3 years from 2014 by the Danish Innovation Fund, which promotes networks, collaboration, and partnerships to strengthen the competitive edge and sustainability of Danish businesses (Biopeople 2018). The project was led by three university-based innovation networks—Biopeople (life sciences), InifinIT (IT), and Brandbase (consumer studies)—that work to establish and expand collaboration between university research and business, together with a private research and development organisation, Bioneer. The main aim of the biomarker project was to generate cross-sectoral networking to support the development of biomarkers. The assumption underlying the project was that gathering stakeholders into a network to exchange needs, views, and knowledge would give rise to common ideas and aspirations (Brogaard 2021). In the case of biomarker projects this should ultimately lead to faster development of biomarker tests for use in clinical practice as a means to better diagnostics and more individualised medical treatment (personal medicine or precision medicine). In other words, the overall aim of the project was not yet innovation but, rather, to create relations that might have the potential to turn into product and perhaps also process innovation at some later point (Brogaard 2021).

Tissue and blood samples in sufficient amounts are the basic ingredient in biomarker research and development. In that sense patients have always played a central although passive role, since research relies on their donations; the notion and practice of patient centricity, however, introduces patients and their ideas as active partners. Patient centricity acknowledges patients as actors with their own goals, wishes, and preferences, allowing new positions and new kinds of collaboration to emerge.

The authors of this article, all anthropologists, were invited onto the project to fulfil the Innovation Fund’s requirement that three partners should collaborate, preferably across disciplines, and to ensure that project outcomes would be patient-centred. We translated this aim into practice by setting ourselves the task of exploring POs’ interests and facilitating their involvement in the biomarker network through discussions with those relevant to the researchers’ biomarker focus. We joined project seminars, meetings, and networking events, and interviewed representatives from six patient organisations and three life science companies, as well as independent researchers based in university hospitals or contract-based research institutions who, in one way or another, had been involved with the project examined in this article. We thereby played an active role in facilitating POs’ participation in the biomarker network, which provided us with insights into interactions and negotiations between distinct types of collective actors—in this case, organisations, institutions, and companies.

Against this backdrop and by means of situational and social arena analysis (Clarke et al. 2015; Clarke 2003; Clarke and Montini 1993), we explore the negotiation of discourses, images, and positions that unfolded between POs, public sector researchers, and the life science industry. In this we differ from studies that explore how patient perspectives influence agendas and activities (Rabeharisoa 2003; Epstein 1995) or studies of instruments to measure the effects of patient engagement on quality or relevance (Bird et al. 2020).

The existing literature on patient involvement has effectively described how power imbalances influence the way patient voices are heard and their contributions taken into account (Bird et al. 2020), and how patients must walk a fine line in collaborations in which they are supposed to act as naïve actors, uninfluenced by expert knowledge (Lehoux et al. 2012; Jacobsen et al. 2015). With a focus on collective actors—the POs—rather than the individual patient, our analysis contributes a twist to these findings; indeed, the involvement and balancing acts of POs appear even more complex than the involvement of the individual patient, clarified in the thorough analysis of the literature on the positions of POs in the literature section. The article thereby contributes to the existing literature by demonstrating that contemporary POs must adopt multiplayer positions in order to fulfil the many diverging demands put on them—in the name of patient involvement as well as development and influence.

Methodological considerations

Our methodological and analytical choices are inspired by Adele Clarke’s adaptations of Strauss’ situational analysis and social arena analysis (Clarke and Montini 1993; Clarke 2003; Clarke et al. 2015, 2018). Situational analysis is a theory/method package with roots in grounded theory, symbolic interactionism, pragmatism, and ANT, with inspiration from the work of Michael Foucault and Donna Haraway. It is characterised by its anchor in social life in all its complexity, contradictions, and ambivalence, which allows researchers to analyse complex situations, social change, and power relations. Moreover, situational analysis builds on the assumption that both human and nonhuman actors—actants—structurally condition the interaction within a situation. Lastly, the method also considers the researchers’ own positioning, through embodied experiences, participation, and situatedness (Clarke et al. 2015, p. 12). We decided to use this method during the analytical phase as it matched our need for a method that addressed complexities, social change, and power relations, while also accommodating our own role as researchers who were part of the phenomena we were studying.

In situational analysis the basic analytical unit is the situation of inquiry broadly conceived, rather than a priori categories. A situation is not merely a moment in time; rather, it usually involves somewhat enduring arrangements of relations among different kinds and categories of elements (Clarke et al. 2018, p. 17). The diverse elements of a situation should be taken into consideration, including humans, objects, practices, discourses, organisations, and institutions. This conceptualisation obliterates the distinctions between the micro, meso, and macro levels (Clarke et al. 2018).

Another central concept is that of social worlds—building on the work of Mead (1972) and Strauss (1978)—which is defined as a grouping of indeterminate size with a life of its own (Clarke and Star 2008). Social worlds meet in arenas of concern in which their members’ agenda is pursued (Clarke et al. 2018). Such arenas are constituted by multiple social worlds all committed to a particular issue, and multiple actors in all kinds of relations, negotiations, and possible conflicts, who are prepared to act. In arena analysis the researcher endeavours to understand the world on the actor’s own terms, normally demonstrating that there are not only two sides, but multiple perspectives in situations, negotiations, or conflicts (Clarke and Monitini 1993), and a full array of situated knowledges related to a particular phenomenon (Clarke et al. 2015, 2018).

Applying this analytical framework, we explore the delicate positioning of POs in an arena of concern formed by the constitution of a network for stakeholders in biomarker research and development. With inspiration from Clarke and Montini (1993) and McGowan et al. (2017), we focus on discourses, images, and positions within the social worlds of POs and industry funders, thereby joining ongoing discussions about how collaboration might threaten POs’ independence from commercial interests (McCoy et al. 2017; Mandeville et al. 2018). We demonstrate that legitimacy, representation, and independence is at stake for POs in their interactions, negotiations, and collaborations with the other actors in the arena of concern.

Methods and empirical data

The empirical data for this article stem from the Danish biomarker project described above. While legislation and the concrete actors are specific to Denmark, on a general level the case offers an example of how discourses, images, and interests intersect that is relevant across national settings.

Our study design was to a certain degree shaped by the organisation and activities of the project itself, as we interviewed key members of the POs engaged in it and observed its activities. During its first phase, we mapped the interests, positions, and discourses of the different actors including POs, researchers, and life science companies. Prior to this we had performed an analysis of the websites of all the POs involved in the project, with a focus on each one’s profile in terms of member support, advocacy and particularly its engagement in research activities. Based on this, we conducted introductory interviews with six of the involved POs (a further two did not respond to our invitation), questioning them about their knowledge of medical research on biomarkers, their interest in medical research, their own positions, and their viewpoints of, and relationship to the other POs, researchers, and life science companies involved in the project. We also contacted three life science companies with connections to the topic of the project, which all agreed to participate, as well as seven public sector researchers, of whom three agreed to take part. The researchers were either related to the biomarker project or were asked for an interview at a later point when we found them in a collaborative role with the POs that we encountered during fieldwork. Interviews were also conducted with the initiators of the biomarkers network. The interviews had the character of open conversations in which we presented the project and its planned activities and asked our respondents about their interest in biomarkers, their experiences of collaboration with patient organisations/researchers/industry, and their interest in and knowledge of patient involvement in medical research.

Parallel with the interviewing, we carried out participant observation in project seminars and meetings related to the topics of biomarkers and precision medicine over a time span of 3 years and participated in several workshops on topics such as facilitators of, and barriers to collaboration between patient representatives, life science companies, and public sector researchers. As part of the project we also organised a cross-sectoral seminar on patient involvement in medical research which addressed the associated operationalisation and challenges and included presentations by stakeholders from governmental institutions concerned with patient involvement, industry representatives, and POs. Lastly, as part of writing the final report and the present article we organised a focus group meeting with POs where we presented our preliminary results and asked representatives to comment on them.

We transcribed and coded all the interview data and collectively conducted reiterated readings of the material, identifying and discussing themes and axial codes (Miles and Huberman 1994). Following the guidelines of situational analysis (Clarke et al. 2018), in the first stage of coding we mapped the different human and non-human actors, the relationship between them, the social worlds of the collective actors, and, lastly, the discourses and positions adopted. In a second round of coding we extracted images and actants based on the mappings as a way to begin to structure our analysis. As we ourselves were part of, as well as actors in the field we were studying, we also analysed our own role and position as part of the material and discussed it with the group of researchers and our interviewees.

Ethics

We have been careful to be as transparent as possible about our purposes and their benefits for POs in the project period, and offered patient representatives the opportunity to influence our interpretations. Because of the sensitivity of POs’ interactions with the life science companies and public sector researchers that we describe in this article, we do not name any of them, nor do we refer to the types of ailments or medicines around which the POs mobilised.

Analysis

Our analysis is structured into three parts. Part One provides a brief analysis of the literature on patient involvement and cross-sector collaboration in medical research, presenting the principal positions that POs have assumed in relation to researchers and industry. Part Two presents and analyses the genesis of a research report on the project’s progress, illustrating collaborative practices among the actors in the arena and how the various positions described in the literature may come into play in practice. Part Three dives further into the subject by analysing the collective actors’ social worlds. Inspired by Clarke’s situational analysis, it consists of three steps: (1) presentation of the collective actors and their discourses and images; (2) description of how collective actors balance images and discourses in their interactions and how this influences their commitments; and (3) analysis of how collective actors position themselves, with a focus on smaller POs.

Part one: patient organisations’ positions—as described in the literature

The history of POs’ interaction with public sector researchers and the life science industry is one of constant overlap and transformation; this is reflected in the literature, which can be organised into studies that cluster around the various positions adopted by POs—both concurrently and serially—as: (1) distanced funders of public sector research; (2) suppliers of data, tissue, and blood; (3) active stakeholders in setting research agendas; (4) partners and lobbyists; and (5) as appointers of patient representatives in the name of patient involvement. We end this section by comparing the positions presented in the literature with the positions assumed by POs involved in the biomarker project. We conclude that their challenge is to master all the positions and then decide when to inhabit each of them.

Position one: patient organisations as funders of health research A number of POs have been actively involved in research as funding agents for many years. By offering seed money to young researchers, they have stimulated the growth of the research environments concerned with their particular diseases (Rabeharisoa and Callon 2002). Despite their clear strategic interests and investment in research, however, they have traditionally kept researchers at arm’s length by, for example, letting independent research councils make the grant decisions (Rabeharisoa and Callon 2002).

Position two: patients as suppliers of tissue and data to clinical trials and biomarker research Traditionally, Danish public hospitals have provided patient data for research, particularly in the field of biomarker research, but POs have begun partnering up with researchers at public hospitals to establish biobanks in Denmark, just as has been seen abroad (Novas 2006). Indeed, with the realisation of the value of access to patient data (Stein et al. 2018), new ways of enrolling patients directly through advertising are being assessed. Despite its small population of only 5.8 million, 12% of all European research proposals for clinical trials of pharmaceutical products stemmed from Denmark in 2017, of which 58% were commercially financed and approximately 18,000 patients were expected to be enrolled (Danish Medicines Agency 2018, Yearly Report). Patients’ interest in participating in trials matters and has become a topic of surveys (fx Medwatch 27.2.2017. Bred interesse for kliniske forsøg blandt danskerne’/broad interest for clinical trials among Danish citizens’).

Position three: patient organisations as agenda-setting agents The AIDS Movement of the 1980s is often described as having had a ground-breaking influence on the relations between research, patients, and companies, introducing patients as partners (Anderson and McCleary 2015). As described by Epstein (1995, 2011), activists decided to put pressure on the development of medicine, testing, and licensing in their quest for faster development of a cure for AIDS. Acquiring sufficient biomedical knowledge to enter into dialogue with researchers, they accessed laboratories, questioned research practices, and posed ethical questions, using the skills and initiative gained through years of grass root advocacy for human (gay) rights (Epstein 2011). Since then, the involvement of advocacy groups has become still more publicly approved and institutionalised (Barnes and Cotterell 2012), with POs taking up positions as stakeholders in political agendas; as such, they engage in a still wider range of political decisions, from the prioritisation of research grants to licensing decisions and the prioritisation of medicines. “What was radical in the 1980s is now an established part of the health and social care system”, as Barnes and Cotterell (2012, p. xxv) express it.

Position four: patient organisations as partners and lobbyists For many POs, donations from the pharmaceutical industry are an important source of income (Mulinari et al. 2020; Fabbri et al. 2020; Khabsa et al. 2020; Mulinari and Ozieranski 2018). In an older Finnish survey (2003) 71% of POs reported that they had received financial support from drug companies, and many considered this financial support necessary to their income (Hemminki et al. 2010). In Denmark, financial support for POs from the life science industries increased by 60% from 2014 to 2016, amounting to 14.6 million DKR by 2016, according to the Danish Association of the Pharmaceutical Industry (www.lif.dk). Danish hospitals received an equivalent amount. Likewise, the industry in the UK more than doubled its annual sum of donations to POs from 2012 to 2016 (Ozieranski et al. 2019).

In a parallel development, there is a growing tendency in the pharmaceutical industry not only to fund, but also to found health advocacy organisations (O’Donovan 2007). These are appealing because they can attract media attention to their disease area, which is a requirement for treatment or research; they can contribute to the implementation of policies and initiatives like early detection; and they can employ political pressure to drive rapid change. Consequently, they are linked to promises of fast-track biomedical advances that not only benefit patients, but also provide financial incentives for the producing companies (Callard et al. 2012; Anderson and McCleary 2015; Hoos et al. 2015). Although actual experiences with fast-track biomedical advances based on the involvement of POs are few, expectations are high, and the life science industries are only too happy to finance summits that help advocacy groups to become aware of these assets and to become more professional in undertaking advocacy work (see, for example, discussion of the Pfizer-financed summit for breast cancer advocacy groups in Özmen 2018). The life science industries are open to offering financial support for this kind of collaboration, and engage in formulating ethical guidelines for its conduct (Stein et al. 2018).

Position five: patient organisations and health research in the context of expanding discourses on patient involvement In recent years a powerful discourse on patient involvement has expanded from a general imperative to one that addresses patient involvement specifically in health research. This has been stimulated nationally by the establishment of organisations such as INVOLVE in the UK (NHS-initiated) or PCORI in the United States (Domecq et al. 2014). In Denmark, government policy also encourages patient involvement, although this is less established in formal organisations. The rationale behind patient involvement in this sense is a democratic one—people are inherently entitled to participate in research that affects their own lives (Carter et al. 2013)—and increasing numbers of funding agencies and institutional missions are demanding that researchers take patient involvement into consideration in their research (Bombak and Hanson 2017), this biomarker project being a case in point.

Patients and researchers, however, are not automatically signing up for this kind of collaboration, although many experiment with it in practice (Brett et al. 2014), thus policies to increase patient involvement in research are aimed at giving patients a voice in matters important to them. Yet it seems that, in practice, this often takes place within institutional frameworks, with employed researchers as chairpersons and agenda-setting agents, and the patients as guests being given a chance to be heard. Consequently, there is a possible tension between civil rights movements and the identity of activists, on the one hand, and the invited patients involved in research as co-researchers or experts in their own lives, on the other (Barnes and Cotterell 2012). The latter may have developed the right kind of skills through education to be able to contribute (Bombak and Hanson 2017; Moltu et al. 2012) but their legitimacy may still be questioned by researchers if they are believed to have their own agenda. As described by Lehoux et al. (2012), the ideal involved citizen is the one who, perhaps out of generosity and a sense of common good, gives advice to those who set the agenda and have the ultimate power to make the decisions (Lehoux et al. 2012).

A mix of positions

The POs that participated in the biomarker project all adopt more than one of the positions described above. Some were established by public sector researchers decades ago and began as funders of health research and, while their initial focus has been augmented by efforts to provide services to their members, research is still an important priority for them. Possible positions as lobbyists are manifold but perhaps most clearly exemplified by POs’ collective representation via the umbrella organisation ‘Danish Patients’ in the Danish equivalent to the British National Institute of Health and Care Excellence (NICE) called the medical council or medicinrådet. In another role, they actively contribute to patient involvement by arranging contact with members when volunteers are needed to participate in research and quality development projects. As organisations, they accept invitations, such as the one to the biomarker network, although their role in the network is only vaguely defined. The researchers’ need for tissue and blood donations was never a topic for discussion in interviews or project meetings involving POs, yet there is implicit acknowledgement of the requirements of research in that one of the organisations helped co-found a biobank. Last but not least, they all strive to promote their agendas in the political sphere.

From this observation it follows that POs no longer merely rely on one or two positions in relation to medical research. Instead, they strive to master them all and then decide which to operationalise in a given situation. To give the reader an impression of the way POs shift between positions in the collaboration practices that we analyse in this article, we present a case story as it evolved during our project period.

part two: what collaboration between sectors may look like in practice: the genesis of a neutral report

During the project, we worked with six small and medium-sized POs whose members used somewhat similar pharmacological products, while the smaller organisations in particular aspired to greater attention and influence than they had the funding and manpower to attain. Aware of this challenge, at some point one of the smaller POs tried to gather together a group of organisations representing patients with comparable chronic conditions and, accordingly, common interests—an attempt that was not successful.

Things changed when a pharma company in close dialogue with an experienced, respected medical doctor working in a public hospital proposed that they join forces under a common umbrella organisation. The medical doctor pointed out that although the illnesses represented by the patient organisations appeared rather different on the surface, they shared a number of important biological mechanisms, and certain types of pharmacological products seemed suitable for most of them. In other words, based on a biochemical similarity they could cooperate and thereby potentially grow in terms of representation and impact. The pharma company already knew all the POs and, on a personal level, a sizeable number of employees in the pharma company, the POs and the clinic knew each other from earlier employment and collaboration.

Five POs agreed to join but two declined the offer. The latter were both medium sized; their prime income was based on donations from foundations, fund-raising activities, and heritage donations, and they were important players in policy development constituted by, and to a certain extent dominated by, clinical researchers. As they feared losing their legitimacy, they avoided overly close collaboration with the life science industry. The five smaller organisations engaged in the endeavour and formed an umbrella organisation, telling us in interviews that they needed the collaboration with the life science industry to supply them with funding.

As one of its first steps, the new umbrella organisation required a strategy and hired a professional communication bureau to develop one. The POs under the umbrella wanted to investigate their shared challenges, and the communication bureau advised them to get help for this task from independent researchers. In response, the umbrella organisation commissioned a qualitative and subsequently a quantitative research report from a well-known independent research institution that also does contract research. With this, the umbrella organisation consolidated its members as a plurality yet with a common cause—an example of the politics of singularisation (Rabeharisoa et al. 2014). The pharma company donated the cost of producing the research reports as well as the fee for the communication bureau but otherwise stayed ‘at arm’s length’, as they explained to us.

Researchers from the independent research institution, external clinical advisors, including the above-mentioned doctor, and volunteer workers from the five POs under the umbrella closely collaborated on the survey. Together, they formulated and revised a questionnaire which was then distributed to members of the five organisations and further distributed via Facebook to other patients who identify with them.

The report was well received and almost everybody was happy with it. Only the national authorities responsible for managing pharmaceutical expenses in public health care were concerned, to the extent that they made an informal call to the contract research organisation inquiring about the impartiality of the research process; it had, however, followed clear guidelines with respect to its neutrality. Furthermore, its legitimacy was enhanced by the fact that it was hired directly by the umbrella PO. However, as the interviewee in the research organisation added, ‘The customers most eager to influence our research questions and presentation of results are seldom from private companies.’

The national authorities’ concern is easy to understand. As the questionnaire was developed, two key questions about patient involvement were included: “Have you been introduced to alternative treatment options?” and “Have you been involved in decisions about your treatment?” While these questions may in some contexts appear neutral, they were not in this case. The national authorities are struggling to manage treatment costs via strict clinical guidelines for the use of expensive pharmaceutical products. The choice of treatment alternatives for this group of patients will in fact often be between a more expensive treatment and a cheaper one that all patients are offered first, according to the clinical guidelines. Hence, the apparently neutral patient involvement questions in the questionnaire can also be seen as highly political queries about patients’ rights to determine their own treatment, no matter how expensive, versus the public authorities’ need to manage the distribution of limited economic resources. Moreover, from a third perspective, the survey questions that could be seen as representing the quest for patient involvement, could also be seen as an instrument for the pharma industry to put pressure on the national authorities, whose clinical guidelines do not favour their products.

This case serves to illustrate how the positions of POs described in the literature may all become relevant over time in the complex collaboration between POs, researchers, and the life science industry. It demonstrates both the interdependency of POs and the positions of other actors in the arena of concern, and the way they readily slide from one position to another in the various interactions. It might even be postulated that collaboration can be so close that it becomes problematic for the legitimacy of POs as independent actors; indeed, to use an expression that exists in Danish as well as English, it can risk the accusation that they are ‘in the pocket’ of the life science industry. This is particularly pertinent for small POs.

At the same time, the case points to the importance of certain discourses, images, and positioning that emerge as we look more deeply into the rationales and motives of the collective actors in the biomarker project. It becomes apparent that simple problematisations of collaboration and interdependence are not sufficient to understand what takes place and what is at stake, especially for the smaller POs.

Part three: in whose pocket? collective actors, discourses, images, and positionings

Applying situational and social arena analysis (Clarke and Montini 1993; Clarke et al. 2015, 2018) in what follows we map out the human and non-human actors in the arena of concern: the discourses, images, and positionings of POs, public sector researchers, and pharmaceutical companies. We proceed in three interlinked analytical steps adapted from Clarke’s model of situational analysis, focusing on relational mapping and social arena analysis (ibid.). In the first step we analyse the collective actors and their relationships and interactions, guided by the question: What collective actors, images, and discourses are present? In step two we analyse how the discourses and images surfaced in the interactions between the actors and how they came to influence their interactions. In step three we analyse the positions taken by the POs.

Step 1: a presentation of the collective actors, their discourses, and images

The collective actors

While the biomarker project predefined the primary collective actors and set the frame of the arena in the sense of generating organised contact, the social arena of concern was much larger and less well-defined than the scope of the actual network meetings. The biomarker network called network meetings to allow potential stakeholders in future biomarker development to meet, but the collective actors had shared interests that extended beyond the goal of the biomarker project and well into a general common interest in better treatments. Consequently, the scope of our analyses extends to the three collaborative partners—POs, life science companies, and public sector researchers—who actually assembled at the biomarker network meetings, but also to some who did not; thus, we attend to the collaboration in the meetings, but also to some taking place outside them. Although this project never involved the public authorities, they feature as important actors in the arena, since much of the collaboration between the three active partners aims to influence them. Furthermore, the authorities (broadly defined) are responsible for setting the rules and regulations that condition and contribute to the possible ways that actors may interact, as well as providing some of the funding in the field.

The discourses

Two prominent discourses influence collaboration between the collective actors in the current study—those framing biomarker development and those framing patient involvement. Both biomarker development and patient involvement are intertwined with notions of hope and expectations (Novas 2006). Research, while still in its infancy, is undergoing rapid development in both fields, and associated with high expectations for future achievements. The discourse of biomarker development holds the promise of a new era of improved diagnostics, personalised/precision medicine, and more efficient testing of new medicines (Callard et al. 2012, p. 390). Research in biomarkers is linked to the hope of earlier and more accurate diagnoses, as well as visions of tailor-made treatment that matches the individual’s biological and genetic profile. The discourse of patient involvement is associated with promises of better health care, more balanced power relations, empowerment, democratic rights, and legitimacy (Van der Scheer et al. 2017, p. 234).

While our data exhibit the hopeful orientation towards the future of the two discourses, a more prominent and surprising observation was that the identity of the main non-human actant biomarkers themselves was not clearly defined by the various actors in the project. Although the development of biomarkers was the reason for bringing the collective actors together, a common understanding of the phenomenon and undertaking was difficult to find; with reference to Clarke and Montini (1993), both the latter could be described as having unstable and multiple referents. Biomarkers were concrete results of research based on advanced studies of samples of blood and tissue. What mattered for some of the actors in the network in that respect was securing access to biological material and engaging investment partners who could realise the potential of biomarker use in clinical treatment. For others, what mattered was the potential for insight into new, although vague, possibilities for treatment. In that sense biomarkers were not merely biological entities but were formed and understood by the way they were linked with collaboration agreements, investment interests, and ideas about their unknown potential for precision medicine. As such, biomarkers were simultaneously measurable biological markers, future instruments in treatment, and an element in a form of precision medicine that would secure treatment with fewer side-effects.

Likewise, the potentials of patient centricity and patient involvement were optimistically invoked, and PO representatives were invited to project seminars to discuss how to enhance development and research in biomarkers and precision medicine with researchers and company delegates. But, again, a common understanding of patient centricity and involvement was difficult to find. In that sense, although these two discourses set the framework for the interaction between the collaborating partners in the current study, a common understanding of the concepts and the specific role of POs was never consolidated.

This became particularly evident in a cross-sectoral seminar in which the invited participants were asked to discuss and define the potential of patients’ involvement in biomarker research and development. As co-facilitators, we struggled to help the participants find common ground, but few had anything specific to say about patient involvement in this context, although participants from both the life science industry and POs were eager to pinpoint the general potential. In the end, the seminar did not lead to any conclusions or further developments, but rather served as another meeting place for collective actors who had common interests on a broader scale.

Overall, we found that the discourse of patient involvement was valued but also criticised by POs. On the one hand, they value patients’ involvement in medical decision making as in the case described above; on the other, they criticise patient involvement in research and development as being a surface framing with little content. They referred to the biomarker project, but also their experience in relation to other projects. The participating POs value patient involvement but are increasingly weary with the outcomes. As one interviewee put it, “Whenever they design a questionnaire, they ask us to comment. Then they can say that they have done that”. The organisations are not sure whether their contributions have an impact or merely serve to legitimise the researchers’ or the policy-makers’ endeavours.

The images of the collective actors

Co-existing with the two discourses described above, which brought the collective actors together, we identified several recurring but self-contradictory images of the collective actors. Pharmaceutical companies are seen as having double-sided images. On the one hand, their patient-relations managers, with whom POs interact, are all described as ‘nice’, ‘friendly’, and ‘eager to find out what is good for us’, yet in the data we find descriptions also offered by POs that pharma companies are profit-maximising, suspicious entities who must be kept at arm’s length to avoid the common accusation of POs’ being in their pockets (meaning they are paid and thereby steered by the companies). Actual collaboration with companies, however, leaves both organisations and researchers with a good impression and trust in their common interest in following the ethical codes of conduct for collaboration, such as those defined by the Danish Organisation of the Pharmaceutical Industry (LIF).Footnote 1

The image of public sector researchers is very vague in our data. They are presented by both POs and pharmaceutical companies as neutral, disinterested partners, who want to conduct high-quality research and are guarantors of scientific merit. All POs have a news feed on their webpage with news from their research area. Nonetheless, while everyone may have an interest in upholding this image, the researchers may in fact be less neutral than imagined, as our case study above illustrated.

Patient organisations are perceived by all other collective actors in our study as both representatives of patients and as avenues for access to research subjects, but primarily as partners in generating public awareness and as a legitimating voice in political debates. As one PO leader said, “We have a certain legitimacy since we can inform politicians of the consequences of their recommendations for people. In this way we can push an agenda”. Or, in the words of a researcher, “If you want to make a change in the system, and that can be done as part of a research project as well, then you need the patient voice. If I say it, I am just one man, one researcher. If the patient organisation says it, they have spoken for thousands of people”. On the negative side, some POs are described as ‘shrill’ by some of those interviewed (POs and researchers as well as consultants from companies), meaning they scream too loudly and listen too little to perspectives that differ from their own.

Step two: balancing images and discourse in interactions

The discourses and images discussed above represent diverse ways of understanding the position of POs. In what follows we highlight how each of the collective actors strikes a balance between the same set of mutually constituting but also opposed discourses and images. Generally POs performed a balancing act between two conflicting discourses and several contradictory self-images of themselves as actors that called for considerable negotiation: while POs sought and were invited into collaboration and alliances with researchers and life science companies to promote improved treatment, it is felt they should be independent and avoid ‘conflicts of interest’.

In this section we demonstrate that actants, such as size, visibility, and funding, were issues of concern for all, and central to the balancing acts. These are analysed as matters of legitimacy, representation, and independence, which are closely interrelated. Below we try to separate them analytically, showing that the balancing acts are particularly challenging for smaller POs. We close by tracing exactly how these matters are interwoven and the positions that become available to (smaller) POs as a result.

In recent years, the need to prioritise the offerings of its health services has come to play a prominent role in debates and policy making in the Danish health care system. The Danish, tax-financed health-care model cannot keep up with ever-growing demands stemming from increasing costs and the treatment requirements of an aging population. This discourse of prioritisation produces more or less implicit competition between different illnesses, some of which seem to get more attention, more research, and more costly treatments. Some causes are more legitimate than others. If your organisation and cause appear sufficiently legitimate, your treatment area can become part of a political agenda; public resources may be allocated from the national budget or your illness may be targeted for public finance. As the director of one PO put it, “I want to have [the illness related to my patient organisation] on the map in line with diabetes and maybe cancer too. These organisations are skilled, and they are huge. Moreover, you can die of it. That is what generates the cover pages and politicians’ interest and thus resource allocation”.

Medium-sized organisations are aware of these cumulative relations between prioritisation, funding, and political awareness, and they act accordingly. As one PO representative explains it:

We act strategically to get a focus on our research area. We go out and support some students so that they get prizes and do some intro scholarships, which are half a year’s salary or a full year’s salary. ...And then we also support PhDs. We typically distribute smaller amounts because this gives the projects something like a blueprint to go out and seek more funds; so that is what our strategy is.

This example shows how crafting a legitimate cause constitutes an active effort, not only by POs but also by researchers from different research areas competing for grants.

Visibility and representativeness obviously matter in the strategic effort to gain legitimacy. As described above, one way to gain visibility is to generate an increase the number of researchers engaged with one’s disease. Alternatively, visibility can be about the number of articles published. One way to highlight representativeness is to communicate the high number of members in one’s organisation or, at least, the number of affected people in the population. As shown in the case above, pooling symptoms or diseases and research that documents numbers and substantial suffering is one important strategy. A patient-solutions manager from a pharma company frames it as follows: “It is members that give the mandate to persuade politicians, industry, the media, and stakeholders. If you can say you represent thousands, then you get a much greater responsiveness from your stakeholders. …That is clear”.

Being small seems to be a central topic in the interviews with smaller POs, who see it as inhibiting them from receiving the awareness and political influence they want, and the funding that they desire to raise that awareness. Representativeness matters, because it can be a prerequisite for visibility and awareness, but also because it is closely related to funding.

Central to many of the connections we traced between actors, discourses, and images were the flows of funding. Pharma companies contribute financially to awareness campaigns and, as illustrated in the case above, to professional communication and POs’ commissioning of independent research. POs donate money to researchers, and researchers have greater chances of receiving funding if they involve patients. Most POs take a membership fee which is small, and symbolic to the majority; however, it is key to creating further fundraising activities, which is in turn key to receiving a larger proportion of the charity distributed from the public lottery surplus.

To small POs, this cumulative logic poses a huge problem. As a director from a small PO explains it, “Are you 80,000 members and 50 full-time employees? Well then, you can do it all yourself. This is a luxury that the smaller patient associations do not have”. Smaller POs with perhaps only 5000 members may not be able to find the money to register for fund-raising activities or may consider this kind of investment too risky and hence are left behind in the competition for state funding. "So, we need—if we want to reach out—to work with the pharmaceutical industry as well as others who can fund the projects we want to focus on", as a director of one of the smaller POs formulates it.

Funding is a pivotal factor in gaining visibility and this creates challenges for POs in terms of maintaining economic independence, which is closely linked to legitimacy. POs must strike a balance between the moral obligation to retain their independence in terms of commercial interest, and the need and desire to collaborate with commercial actors, thereby facing the danger of being said to be ‘in the pocket’ of whoever is providing them with funding.

As the pharma industry is an actor that can provide funds for research, POs must position themselves carefully in relation to the image of the industry as guided by self-interest only. As phrased by an employee from a large pharma company, “We are the evil; so yes, when people heard that I worked on the other side of the fence it was like, “Ah man, did you go to the dark side?” [Laughs]. After all…we make money because people are sick, that is how people look at it. The pharma industry makes a fortune on sick people, so we are dependent on people being sick”. While interviewees from POs were not very articulate or concerned about the kinds of influence that may follow from financial collaboration and sponsorship arrangements with companies, they were uncomfortable with the negative image of the self-interested pharma industry and the consequences it may have for them if they are not seen as fully independent by other stakeholders.

The self-contradictory images of all actors in this social arena make it difficult to maintain a position in which legitimacy, representativeness, and (in)dependence are well balanced. Our analysis of collective actors, and the discourses, images, and positionings that bring and then knit them together, can be visualised as a tightly woven blanket of interests. With an eye for the awareness that can be raised by a strong research community and scientific merit, both POs and companies make donations to researchers and commission contract research; thus, in the name of patient involvement, POs legitimise the work of researchers, and contribute to researchers’ chances of being funded.

As already noted, POs—and companies—that participated in this study are vague in their descriptions of the value of patient involvement, although certain of the importance of their advocacy work. Their common interest in raising awareness about a disease is key to their interactions. While the companies have the money, POs have the legitimacy to speak out; meanwhile, the researchers provide the scientific merit—and in return get funding. This interweaves the interests and commitments of the collective actors in a social arena where legitimacy, representativeness, and dependence are carefully balanced to align with dominating discourses of biomarker development and patient involvement; the goal is to avoid negative images and adjust positioning to maintain accountability to several different stakeholders.

Step three: positioning space for small and larger organisations

This leads to the last step of the situational analysis, which focuses on positionings. How do POs position themselves in cross-sectoral collaboration with industry and public sector researchers? In Step Two of our analysis we highlighted the mutual and interwoven interests of the collective actors, pointing out differences in the concerns of small and larger POs. In Step Three we further explore differences in the positioning space that is available to them. By positioning space, we mean the range of actions that an actor can take to shape their relations with other actors to reach their goals without compromising the legitimacy, representativeness, and independence that is valued in discourses and images in the arena under discussion. Interestingly, it seems that POs’ relations with public sector researchers are quite stable. From our limited data on the subject it appears that relations with them only enlarge the positioning space of POs in terms of increased legitimacy. This is the same for both small and larger POs.

In relation to the industry the bigger POs reproduced the shady image of the pharma industry as profit maximising and guided by self-interest, and they maintained a position at arm’s length from it. The smaller POs, while sometimes reproducing the shady image, also felt that they could not do much without industry sponsorship, which in turn entailed worry that they might become tokens or be accused of being in the company pocket. They particularly feared the possibility of negative media stories about suspicious industrial collaboration. From the perspective of smaller POs, such accusations might merely be trumped-up charges to prevent their exercising their influence, as an interviewee from a small patient organisation describes:

It is the big [patient] associations that set the agenda there. ...They can polish their glory and say, ‘We do it all by ourselves.’ Yes, it may well be so, but they also have a completely different economy. …As I see it, they want to keep the small fish out, so that the big ones can take all those places. ...It is also a political spin in that they can keep us away [from the political arena]. From something that is important.

Indeed, in spring 2018, The Danish National Ethics Committee documented that political prioritisation has favoured cancer over other diseases. As a participant in our PO focus group commented, “So now it is legitimate to say aloud that prioritisations are skewed. …Earlier we were just said to be jealous if we said so”.

Furthermore, smaller organisations compete for resources to take care of their constituency on what they regard as unequal terms with larger POs. Receiving sponsorship from the industry may be what they must do to get awareness and be heard, like the larger organisations. As an interviewee from a small patient organisation pointed out:

There are lots of important things that would not have been possible if we had not received these sponsorships from the industry. Small associations cannot do without them. So, it’s easier to come from the association ‘Fight against cancer’ and proclaim, ‘The pharmaceutical industry!! These are ugly guys.’ They can easily say that, with the economy they have. We do not have that possibility. There is nothing wrong in what we do; we cannot be like them.

Other POs negotiate the discourse by ‘facing the ghost’, that is, taking seriously the dangers and the fears and then confronting them with regulations. They claim that regulations and transparency in collaboration are, of course, needed, but also that the Danish pharmaceutical industry association has secured sophisticated guidelines that it and its members follow. There are yet others who merely wish to free themselves from financial ties:

There is no doubt about it, and we say this regularly to each other, that it is not something they do for the sake of our blue eyes; it is something they do because they have a commercial interest. Simply. Although we do not discuss medicine and treatment with them, they have an interest in us getting a voice as patients. So, we have an underlying agenda that states that we would really like to be self-sustaining, so that we can act [by] ourselves. (Member of small PO)

To sum up this last part of the analysis, smaller POs have less positioning space, particularly when balancing legitimacy and independence, than large organisations that are able to attract more public funds for research, development, and treatment, which again is linked to more publicity and political awareness. Within this cumulative logic, small POs must work much more carefully to balance financial independence with legitimacy than larger organisations that have access to other financial resources, such as heritage or the state lottery surplus.

Conclusion

The point of departure for this article was our interest in the engagement of POs in a network formed to stimulate research and development of biomarkers. The POs were invited to the network in the name of patient centricity; this calls for patients to expand their former role in biomarker research as passive donors of biological material to become actors with their own goals, interests, and preferences. Patient centricity, although an asset in the project, was never clearly defined from the beginning. Nor was the role of POs. As researchers and co-facilitators of networking activities during the project period, we did not define our own role either, but let the POs and the other public and private actors in the network define it through dialogue at meetings and in interviews with us. While the success of that endeavour can be questioned from a practical point of view (a meaningful role for POs in the network was never established), the process highlighted the negotiations over the positions of POs that are currently taking place.

Against this background we asked: What kind of relationships emerge as POs are invited into partnerships with researchers and the life science industry in the name of patient centricity? And how do they balance legitimacy, representation, and independence in such collaboration? On an empirical level, we found that POs draw from a number of already established positions, which have been described in the literature. However, those that we met do not see themselves as adopting a particular, fixed position; rather, they shift between them while at the same time grappling to find the most advantageous stance in the new quest for patient involvement in research and development. From that ‘melting pot’ a new ‘multiplayer position’ seems to have emerged, and we found POs of all sizes trying to promote their agendas by grappling with this new placing. Smaller POs, which are weaker in terms of manpower, the economic cost of activities, and public visibility, are particularly vulnerable, as they have less positioning space and it is more difficult for them to balance legitimacy, representativeness, and (financial) independence.

On a theoretical level, situational analysis helped us to understand how collaboration between POs, researchers, and the life science industry are much more complicated than the current literature on the problematic nature of economic ties and their implications would lead us to believe. In an ongoing balancing act, POs are situated between the quest for collaboration in the name of patient involvement or innovation (or both) and the demand for independence and neutrality to maintain legitimacy, which they can both generate and compromise through collaboration with other (commercial) actors. The analysis also showed that the collective actors and their interests are so closely interwoven that it may distort our understanding if we keep perceiving the collective actors as inhabiting different social worlds that merely make contact in a common social arena of concern. We need a theoretical concept that encompasses the massive interdependency between collective actors which, while they may appear as distinct entities each with its own image and position, depend on, and affect the available positions of each other to such an extent that their social worlds seem to be merging. If we are to understand the interdependencies between researchers, POs and the life science industry, we need to revisit their ties; indeed, it could be helpful to see all three actors as part of the same system and investigate ‘cumulative drives’. In this case, the latter manifests in the universal goal of greater public awareness: small POs strive for greater public awareness of their cause and the concomitant political impact it supplies; awareness is a requisite for life science companies that wish to expand their markets; and awareness also supplies more funding opportunities to public sector researchers. The cumulative drive in this system is sustained by institutionalised mechanisms that award a larger proportion of public resources to organisations with more members and stronger fundraising activities, and favour researchers who involve patients when grants are distributed. In that sense economic ties are cumulative drivers as well.

Discussion

It may be relevant to discuss the dangers of the cumulative drives described above; however, this needs to be done in a nuanced way. The real problem, as we have shown, may not be that POs risk their economic independence and wind up ‘in the pocket of the industry’, but that all partners depend on one another economically and otherwise. In a sense, all the collective actors are ‘in the pockets of one another’. How does such interdependence form pathways to new treatments and what does it do to priorities?

Our analysis contributes a more critical and nuanced understanding of the changing and mixing of positions and the moral knots that unite the actors than studies that focus on highlighting how the engagement of POs may help to democratize science (Rabeharisoa 2003). This insight has political implications and provides a step towards a new research agenda. As it becomes imperative to listen to patient voices, interest in forming POs and influencing their contributions and positions is growing. Hence, it is important to investigate the full range of stakes in POs’ relations with other actors in this arena of concern, not just funding and regulatory practices which, as our analysis of the existing literature demonstrated, has mostly been the case to date.

There is a need for more nuanced research into the balancing acts involved in shared interests and economic ties between stakeholders, but also for a more critical investigation of the ways such research and discourses about collaboration—both between organisations and in interaction with other public and private stakeholders—enter the POs’ positioning game. Who has an interest in either regulating and blueprinting, or delegitimising a PO’s industry affiliations? And what, in fact, are the means by which POs may best pursue their interests and their aspirations for influence and visibility for their causes? Can the quest for patient involvement be a stepping stone to these goals? Or will the involvement of POs in life science research become or remain a token?

POs may have simple goals (awareness, better treatment for their disease, etc.), but they are entangled in complex relations with public and private actors, and it is time to bring these less visible relations and interactions into the light: not to delegitimise them or silence their voices, but to make space for more transparent collaborative practices between researchers, POs, and private and public actors. It is time to acknowledge that POs need to be interwoven into these complex relations to be relevant. And it is time to support them in fulfilling the potential new ‘multiple player position’ that has grown out of the melting pot of numerous older positions, enhanced by the potential of greater patient involvement.