Physician–industry collaboration: Conflicts of interest and the imputation of motive

Introduction

The governance of physicians’ involvement with pharmaceutical companies spawns contradictory ideas. While some policies perceive physician-industry collaboration as a motor for innovation and economic growth, others picture it as a moral danger. In either case, ‘the clinic’ and ‘the industry’ are seen as distinct domains, and policies are enacted to fix the perceived problems. One set of policies seeks to bring medicine and industry closer together; another set aims at keeping them apart.

To bring ‘the clinic’ and ‘the industry’ together, research infrastructures have undergone reform (Larsen, 2011). Within the European Union (EU), Denmark presents a case characterized by rapid implementation of radical reforms (Bloch and Aagaard, 2012: 103−109). Under catch-phrases such as ‘from insights to invoice’ and ‘Healthy Growth’, policies have been launched by national and regional governments to promote public–private research collaboration (pp. 95−98). Mirroring tendencies in other countries (Adams et al., 2003; Gelijns and Thier, 2002; Will, 2010), public research grants have been made conditional on private co-funding (Aagaard and Ravn, 2012: 175−176), and various initiatives have been launched to ease the administrative burden on private companies that undertake clinical research through the Danish healthcare services (Danish Regions, 2012). By ensuring that ‘health research and innovation is undertaken in close collaboration between public and private research environments’, the Danish Ministry of Health seeks to ‘generate the best results for patients and, at the same time, stimulate development and economic growth in the Danish health industry, which is the largest export sector in Denmark’ (Danish Ministry of Health, 2012, author’s translation). Common to attempts to bring ‘the industry’ and ‘the clinic’ together is the idea that economic interests will motivate researchers to develop knowhow and products that can strengthen Denmark’s competitive position in what is depicted as a global ‘knowledge economy’ (Aagaard and Mejlgaard, 2012: 11).

These initiatives have found their way onto the political agenda in parallel with public criticism of physicians’ industry involvement (Vedel and Gad, 2011). The criticism has given rise to policies to preserve physicians’ professional integrity and measures of transparency to enable detection of potential moral breaches. By law, Danish physicians must seek approval from the National Board of Health to collaborate with pharmaceutical companies, and their names are published on the Board’s website along with company names and the type and duration of their collaborations. ¹ Following parliamentary debate about physicians’ industry involvement (Danish Parliament, 2010), however, the Danish Minister of Health recently announced the preparation of ‘stricter rules for the collaboration between health professionals and the two large health industries [the pharmaceutical and medical technology industries]’ to ‘avoid doubt whether economic interests influence professional recommendations’ (The Danish Ministry of Health, 2013b). Likewise, requirements have been tightened in regard to physicians’ competence to act as advisors for the public healthcare administration (Kraft, 2013). As with the politics of growth and innovation, these attempts to keep ‘the industry’ and ‘the clinic’ apart also place economic interests at the center of human agency – but with a very different outcome. These policies give voice to concerns that industry payments can skew physicians’ decisions because they come to serve the economic interests of physicians rather than patients’ or public interests; in other words, they have a conflict of interest (COI) (Rodwin, 2011: 251–253).

In contrast to these two political stances, I draw on and develop recent research arguing that ‘the industry’ and ‘the clinic’ are not fully distinct domains, but intertwined. I aim to understand how conflicting policy objectives interact with everyday practice in Danish hospitals where researchers must ‘make ends meet’. Taking the case of hypertension, I illustrate how ‘corporate’ and ‘academic’ research is entangled as physicians engage in industry trials to pursue their own research. Indeed, the establishment of industry ‘ties’ can serve as a way for physicians to navigate the constraints of research infrastructures, and live up to intergenerational norms that knit the medical collective together. These relationships shape research production – but in ways that may run counter to the aims of innovation policies and that COI policies do little to address. When the ‘problem’ of physician–industry collaboration is defined as one of COI, it directs attention to financial relationships per se while directing attention away from the political priorities that stimulate the generation of so-called COI. Furthermore, when debate about physicians’ industry involvement begins with an imputation of motive, this can plunge public debates into moralistic ‘blame games’ and lead to the withholding of information that could inform the debate. Based on this, I suggest that analysis of physician–industry collaboration should start exploring the generative potential of moral valuations in economic exchange.

Medicine and industry as intertwined domains

The contradictory conceptions of physician–industry collaboration are reflected in scholarly debate. On one hand, public–private research collaborations are approached as a question of advancing medical innovation and technological dissemination, and analytical attention is paid to research investments (Achilladelis and Antonakis, 2001; Dorsey et al., 2009; Toole, 2007), co-authorships (Cockburn and Henderson, 1996), citation patterns (Sampat and Lichtenberg, 2011), and research and development (R&D) agreements (Adams et al., 2003). On the other hand, a growing literature points out the dangers involved in the merger of ‘academic’ and ‘corporate’ research activities, such as the risks of ‘biased’ knowledge production (Als-Nielsen et al., 2003; Angell, 2005; Bekelman et al., 2003; Chan et al., 2004; Gøtzsche et al., 2006; Hewitt et al., 2005; Mendelson et al., 2011; Turner et al., 2008), unwanted commercialization of science (Caulfield, 2007; Law, 2006; Michaels, 2008; Mirowski and Van Horn, 2005; Sismondo, 2009, 2011), unwarranted alterations of prescription patterns (Andersen et al., 2006), and ‘disease mongering’ (Fishman, 2004; Moynihan et al., 2002). Whether the interactions between medical researchers and pharmaceutical companies are held to produce desired or undesired effects, the scholarly contributions tend to reinforce an image of ‘public’ and ‘private’ as distinct domains either enriched or corrupted through merger.

Contesting this dichotomous conception, a recent strand of ethnographic and historical studies has demonstrated that clear distinctions between ‘public’ and ‘private’, ‘academic’ and ‘corporate’, or ‘basic’ and ‘applied’ science are not adequate representations of research dynamics as they play out in practice (Gelijns and Thier, 2002; Hansen, 2011; Jones, 2009; Lakoff, 2005; Lam, 2010; Schleifer and Penders, 2011; Shapin, 2008: 93–164). From this vantage point, collaboration practices, rather than institutional divides, constitute the starting point for analysis (Vermeulen and Penders, 2010: 5–7); public–private collaborations should be explored ‘without invoking an imagined past of clear boundaries and separations as the basis for a normative stance’ (Hansen, 2011). Drawing on the notion of a ‘moral economy’, ² another group of studies has pointed out that research collaborations cannot be understood separately from the political landscape in which they operate (Atkinson-Grosjean and Fairley, 2009; Martin, 2006; Rasmussen, 2004; Sismondo, in press). They show how physicians and industry representatives express ideas about their collaboration that contrast with conceptions of COI voiced in scholarly and political debate (Martin, 2006; Sismondo, in press), and they suggest that physicians’ ideas of legitimate exchange are shaped by politico-economic conditions of possibility (Atkinson-Grosjean and Fairley, 2009; Rasmussen, 2004). In a similar vein, I seek an analytical space between everyday practice and the shaping powers of societal institutions (Hacking, 2004) when I seek to understand when and why conceptions of physician–industry collaboration contrast and what the resulting tensions may produce. This approach differs from research (and policy) traditions that focus mainly on identifying and criticizing what is coined COI (see, for instance, Bekelman et al., 2003; Brody, 2007, 2009; Caulfield and Griener, 2002; Liang and Mackey, 2010). This is not to deny that the stakes in pharmaceutical knowledge production are high or that economic interests can motivate action in this field. However, when actions are explained through the identification of presumably known economic interests, motivation is often reduced to the possibility of economic gain. Such a one-dimensional (1D) understanding of motivation tends to ignore that action can be guided by factors other than prestige or profit (Shore and Wright, 2011: 3). As Ferguson (1994) notes, a phenomenon is not explained by explicating a given constellation of anticipated interests (p. 13). Moreover, because strategic interests must operate within a complex set of social and cultural structures, actions may turn out differently than intended by the planners (Ferguson, 1994: 17; Pollock, 2011). Indeed, to understand how regulations of physician–industry collaboration sometimes yield consequences that extend beyond the political goals that initiate them, I suggest that analytical attention should be devoted also to the attribution of interests and what such attributions may generate in the social environment.

Entering the field of hypertension research

This article draws on ethnographic fieldwork undertaken in the Danish healthcare services. From September 2009 to June 2011, I followed an industry-sponsored drug trial in four hospital-based research clinics, observing the daily work and engaging in numerous informal conversations with physician-investigators, research nurses, and patient-participants. I also conducted 22 semi-structured interviews with 10 physician-investigators, 8 research nurses, 3 pharmaceutical company executives, and a chief economist from the Danish Pharmaceutical Industry Association (Lif). I attended national and international conferences related to the topic, followed the debate about physician–industry collaborations in lay and professional media, and searched databases and government websites for information about research funding, market developments, and physician–industry regulations. ³

While physician–industry research collaboration takes various forms, this article focuses on what has been termed ‘contract research’, that is, when physicians undertake industry-initiated research for remuneration (Fisher, 2009). The contracts typically specify that physician-investigators must recruit patients, collect and report data, and adhere to data monitoring requirements. In return, they receive remuneration based on the number of patients they enroll. This kind of collaboration is promoted in Danish policy initiatives (Danish Regions, 2012) and has been instrumental in the development of hypertension research. Indeed, hypertension research rose to prominence in tandem with the development and marketing of what came to constitute a burgeoning market of anti-hypertensive medications (Greene, 2007).

My analysis is structured around three empirical questions: (1) How are public and private research resources and activities related in clinical hypertension research? (2) How does contract research interact with physicians’ ideas about academic freedom? (3) When do physician–industry collaborations cause tension for those involved, and how do they deal with it?

In the next section, I start by illustrating how ‘the clinic’ and ‘the industry’ are already entangled and thus do not constitute distinct domains to be ‘brought together’ or ‘kept apart’.

Public–private interlinks in clinical hypertension research

You take the patients; and you’ve got a research nurse; and it’s sort of like you run a business, because you get funds, and these can be spent on PhD. students or other kinds of research. That’s the way you can do things. […] Somehow you need money for your basic research; you know, the clinical studies you want to do. (Interview with staff doctor, 2009)

This is how one physician-investigator explained contract research: it serves as a resource for investigator-initiated research in what she depicted a well-established ‘business-model’ for clinical hypertension research. In her description, ‘academic’ and ‘corporate’ research activities and resources are deeply entangled. Still, she took care to distinguish between ‘industry research’ and her own ‘basic research’ (the ‘clinical studies you want to do’). In doing so, she introduced ideas that seemed to fit neither the ‘Innovation’ nor the ‘Conflict of Interest’ conception of physician–industry collaboration in the public debate. Therefore, I started to track how this form of collaboration works and how it is conceived of by those involved.

In Denmark, research units engaged in contract research are typically established in publicly owned hospitals, and the research activities, which are initiated and financed by private companies, are run by publicly employed physician-investigators. The physician-investigators set up research accounts, engage research staff, and enter into contracts with pharmaceutical companies to obtain a profit that they subsequently invest in their own research activities. In this sense, industry-led research forms part of what the physician-investigators coined their research ‘business’. The influx of private research funds depends on the availability of human and material resources at the public hospitals. A flexible work organization allows contract research to be part of the daily work at hospitals. For instance, research nurses sometimes work part-time in research units and part-time in hospital wards; secretaries may assist with research-related tasks; and consultant doctors are often able to integrate investigator responsibilities into their daily work flow. One physician-investigator explained, ‘Like most executives, you don’t have fixed working hours. […] I’ve got a job description stating that I’m expected to take care of this and that. How I organize it is basically up to me to work out’. Material resources also matter. When guiding me around the research clinics, research nurses often took care to point out the physical facilities they needed to run the trials. For instance, an experienced research nurse explained how she had convinced the hospital administration to install an air conditioner in the medicine depository to ensure that the medication was kept below 25°C, as required by study protocols. When she started as a research nurse, she had been allocated a desk in the hospital basement, without any storage space for the numerous handwritten data records. She noted proudly that she and another nurse had taken part in building up the research unit that now consisted of one office for every trial they ran, a nurse office, a kitchen, and the medicine depository (field notes, 20 May 2010). When I later interviewed a pharmaceutical company’s head of research, the importance of these resources became clear. Asked how she decided which sites to contract with, she explained,

Our greatest challenge is to find out whether [research sites] actually have the resources and the patients to initiate a trial and the resources required for delivering the quality and carry[ing] out all the various procedures demanded by the protocol. (Interview with head of research in a pharmaceutical company, 2011)

Concerned about the company’s ability to meet regulatory requirements for drug safety and effectiveness, this executive emphasized how the influx of private funds through contract research is conditional on available research resources at the public hospitals. Thus, ‘public’ and ‘private’ research resources do not flow in distinct streams; they are premised on each other.

While the collaboration provides pharmaceutical companies with data necessary to obtain marketing approval, it also enables physicians to engage in what they referred to as ‘real research’ or projects they ‘want to do’. Sometimes, physician-investigators negotiate with companies to have their own studies ‘nested’ within industry protocols. In these instances, physicians draw on industry trials to pursue their own research questions. One physician-investigator explained how this took place in a large hypertension trial,

I was in the sub-study committee [in the LIFE-study] […] and many of the sub-study protocols that were of high scientific quality were accepted and funded. […] It was possible to shape [the study] to a large extent and this is not always the case. It was quite unique. (Interview with consultant doctor, 2011)

However, most often contract research offers ‘take-it-or-leave-it protocols’ with no room for negotiation, as the investigator noted. In such cases, the attraction of contract research lies in its ability to generate a profit that allows physician-investigators to fund their own research. One resident put it bluntly: ‘If there wasn’t money in it, the industry thing, I’m not sure we would spend our time on it’. Asked how he generated profit, a physician-investigator explained,

It’s simply about rationalizing and, at the same time, running so many studies … You see, my honorarium is included in the payment from the company, and I don’t get it. Not at all. Whatsoever. I don’t get a penny. Except for my salary, of course. So, that’s the way you do it. (Interview with consultant doctor, 2010)

It is worth noticing that this investigator repeatedly stressed that he does not profit personally from industry collaboration. This suggests he is aware of the public criticism of physicians’ industry involvement and wishes to guard himself against it. I will return to this point later. Also important is that he describes how surplus funds are channeled into his own investigator-initiated research activities. Typically surplus funds function as ‘start-up’ funds for PhD projects and payments for lab tests, research materials, salaries, or conference travels. Says one investigator,

I could tell a student: see, we have some funds. We can fund you two months so you can start writing protocols. […] It is a very typical way to spend these funds. […] They can also be spent on equipment. […] For instance, an ultrasound device you need for your research but cannot afford in the hospital’s operating budget. (Interview with consultant doctor, 2011)

Danish research and innovation policies tend to portray the relationship between ‘academic science’ and ‘industry research’ through a uni-directional logic of production and consumption (Hansen, 2011). ‘Academic science’ constitutes a resource that gains value when it is consumed by industry and translated into marketable products. However, these physicians suggest a reverse dynamic. According to them, industry trials constitute a resource that gains value through its translation into ‘academic science’. Some of the physicians even characterized what they gain from industry as independence. Consider, for instance, this resident’s reflection, ‘It means that we are relatively independent […]. So, in that sense, we do not care about the sponsor. We spend their money’.

This conception stands in stark contrast to the concerns about physicians’ COI we hear in political debates. Following a proposal for parliamentary ‘intervention towards physicians’ conflicts of interest’ (Danish Parliament, 2010), physician–industry collaboration became subject to parliamentary debate throughout the duration of my fieldwork. While the political parties held different views on how to deal with physicians’ presumed COI, they all emphasized that uncertainty about whether healthcare decisions are guided foremost by concerns about patient welfare is politically unacceptable. In its proposal, the left-wing opposition party, The Red-Green Alliance [Enhedslisten], argued that ‘the extensive collaboration between the pharmaceutical industry and physicians’ implies that ‘physicians no longer work solely for the welfare of their patients’ but also ‘to earn money and safeguard their personal ambitions and gain prestige’. In the subsequent debate, the minister of health stated that while the (liberal–conservative) government did not endorse a total separation, ‘conflicts of interest between industry and the healthcare system are unacceptable’. The Minister also announced the appointment of a committee to scrutinize existing regulations, emphasizing that ‘economic interests should not bias medical judgments and decisions’. All the political parties – across ideological lines – supported this initiative. For instance, the spokesperson for The Social Democrats emphasized the need for politicians to ‘ensure that ethics and medical professionalism drive the healthcare system’, and the spokesperson for The Socialist People’s Party observed that the current regulations were insufficient because ‘doubt whether [physicians’ decisions] rested on patient interests, economic interests or both had been warranted’ (Danish Parliament, 2010). Both statements depict economic interests as a driver of physician–industry collaboration, and political intervention is motivated by concern that industry payments may bias physicians’ judgment at the expense of patients’ or ‘public’ interests.

In contrast to this political framing, the physicians I interviewed did not conceive of themselves as ‘bound’ by industry ‘ties’. Rather, they presented autonomy as an outcome of industry collaboration. While these statements may be construed as an attempt to legitimize industry involvement, it is important not to underestimate the information they convey regarding physicians’ perception of the politico-economic conditions for clinical research, such as the organization of research funding systems and institutional pressures towards high research productivity.

In the second part of my analysis, I explore how the establishment of industry ‘ties’ can serve as a way for physicians to navigate the constraints of research infrastructures. I first point out how contract research can provide an opportunity for physician-researchers to pursue research questions that fit neither company R&D ‘strategies’ nor the increasingly ‘strategic’ framework of Denmark’s public research funding system. I then show how contract research has come to form part of an exchange system that ties the medical collective together.

Industry ‘ties’ and academic freedom

Tensions in physician–industry collaborations

Dealing with tension stemming from the imputation of motive

I first return to the investigator who, in the midst of an explanation of a financial transaction, emphasized that he did not benefit personally from contract research. Later, when I e-mailed the investigator to request approval for my use of his quotes, he responded with a single line: ‘I would like it to be clear that I personally do not get a penny; all the funds are paid into a research account’. Other investigators echoed his refrain: ‘[Surplus funds] are always channeled into research; they are never channeled into individual payment’. This inclination to stress that they did not profit personally from industry collaboration indicates that investigators are aware of the public critique of physicians’ COI and seek to protect themselves against allegations. When they are not paid, they cannot be ‘bought’, they seemed to suggest. Significantly, these responses were provoked by what I intended to be technical questions about financial flows. Sometimes I even found it necessary to reassure investigators that I did not question their motives when they started defending their practice against a critique I did not raise:

By emphasizing that industry collaboration can always ‘be put in an odious light’, this investigator also expressed a need to defend her practice against allegations in what she later depicted as a public debate characterized by ‘suspiciousness’ and ‘scandal’ – this time by underlining that collaborations were ‘approved by top officials’. Similarly, a research nurse claimed that ‘the public and journalists don’t have a clue what they talk about when they claim that physicians are in the pocket of pharmaceutical companies […] Actually, I think they [physician-investigators] are like some hunted animal’. To understand why it was important for the physician-investigators to stress that they did not gain personally, we should not dismiss their statements as sheer self-serving strategy, but seek to understand what they have at stake.

In the medical oath that marks their entry into the medical profession, Danish physicians promise that they will ‘use [their] knowledge with diligence and solicitude to serve society and their fellow human beings’. In the Geneva Convention the pledge reads, ‘The health of my patient will be my first consideration’. ⁸ When physicians are publicly criticized for compromising patient welfare because they serve their own economic interests, their professional ethics is called into question. Such criticism was taken to the extreme when the main public service television station in Denmark, Danmarks Radio (DR), broadcasted a documentary entitled ‘When the doctor knows best’. ⁹ While the research nurse used the notion of ‘hunted animal’ as a metaphor, the documentary showed journalists literally chasing a physician around the Danish University Hospital in an almost tragi-comic attempt to make him answer their questions about an industry-sponsored research grant he had received. In June 2011, the High Court convicted the show’s two journalists for defamation of character. The High Court stated that the journalists’ allegations of ‘malpractice resulting in unnecessary deaths and shortened lifespan and motivated by promotion of [the physician’s] professional prestige and private economy’ were incorrect (Eastern High Court, 2011). By drawing attention to this example, I do not wish to suggest that public critique is unwarranted. Indeed, it is well documented that pharmaceutical companies and physicians sometimes circumvent regulations. ¹⁰ My aim, however, is to understand what may happen when critiques impute motives to those engaged in physician–industry collaboration. What is the generative potential of this form of critique?

Conclusion

I have explored how physicians engaged in research collaboration with pharmaceutical companies navigate a political landscape where hopes for new medical possibilities legitimize the search for profit, yet expose these collaborations to moral critique. While the political rhetoric is full of grand hopes and lingering fears, it appears that, in practice, physician–industry collaborations already constitute a shared everyday affair that shapes medical research – but in ways other than those anticipated in the political debate. In the political debate, hope is invested in public–private research as a means of innovation and economic growth, but one with a risk that industry payment will skew physicians’ decisions in a way that disregards or downplays patients’ and ‘public’ interests. Thus, physicians’ alleged COI are seen as the problem of physician-industry collaboration. By contrast, the physicians involved locate the problems elsewhere. They view the danger of industry collaborations as time wasted on trivial research that, nevertheless, nourishes the hope that working with industry will grant them freedom to pursue the research they want to do.

Whereas the literature on physicians’ COI draws attention to influences of economic relationships on medical research production (see, e.g., Psaty and Rennie, 2006; Robertson et al., 2012), this article underlines that the identification of economic interests does not adequately explain why and how physicians and pharmaceutical companies enter into economic relationships. For physician-investigators, industry collaboration can serve as an attempt to navigate the constraints of existing research infrastructures. This, however, creates new obligations that shape research production in ways that may run counter to the goals of innovation policies and which are not addressed by COI policies. When the ‘problem’ of physician–industry collaboration is defined as one of COI, it directs attention to financial relationships per se and attributes (too much) explanatory power to economic interests as the main driver – and the main danger – of physician–industry collaboration. This can direct public debate about physician–industry collaboration away from questions about the political priorities that foster the feared COI, let alone the implications for the resulting knowledge production. While innovation policies tend to assume that contract research is per se valuable, this analysis points to a need for more nuanced consideration of the overlap between clinical, scientific, and economic value generated in various forms of public–private research collaboration. The involved physician-investigators already engage in such complex negotiations; however, often tacitly. Scholarly and public debates about physician–industry collaboration could fruitfully begin exploring these issues further. In conclusion, to understand the conditions of possibility for medical research in an intertwined public–private research environment, appreciation of the ways economic and moral valuations come together in this policy field is necessary.