The Rise and Fall of a Biobank more

!"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:4 1111 2 3 4 5111 6 7 8 9 1011 1 2 3111 4 5 6 7 8 9 20111 1 2 3 4 5111 6 7 8 9 30111 1 2 3 4 5 6 7 8 9 40111 1 2 3 44 45111 3 The rise and fall of a biobank The case of Iceland Gísli Pálsson Aristotle partly defined the ‘simple’ fact of living in opposition to politics. For him, living itself was beyond the activities of the polis and, therefore, by definition, outside politics. As Thrift observes, drawing upon Agamben’s terminology (1995), one of Foucault’s contributions was to shatter this neat distinction, pointing out that, ironically, ‘bare life’ was increasingly politicized, in fact one of the central concerns of the polis: ‘Indeed it is possible to argue that simple natural life is now the most active zone of politics’ (Thrift 2004: 147). Biobanks of the kind discussed in this book illuminate the advance and expansion of the realm of biopolitics. While they differ in terms of structure, history, and context, they all draw upon a series of developments in the biopolitical history of states and bureaucracies over the last couple of centuries and their growing concerns with the monitoring and governing of bodies and populations. This chapter outlines the case of the Icelandic Health Sector Database (HSD), exploring some of the critical issues it has raised (see also Pálsson 2007), the main reasons for its termination, and its implications for governance. In 1998, the Icelandic Parliament ratified a bill on a HSD that would assemble in digital form medical records for the entire Icelandic population. The plan for the database has often been represented as the first population ‘biobank’ of its kind, a model for others to learn from, to imitate, or to avoid. Since its launching, dozens of somewhat similar plans have been discussed or developed in different parts of the world. While many national, ethnic, and regional biobank projects that have, in one way or another, drawn upon the Icelandic experience are on schedule, surprisingly, perhaps, work on the HSD itself has come to a halt. Given the problems and delays of some of the biobank projects launched at the turn of the century – in particular the Icelandic one – one is entitled to ask: are they simply cases of collapse and the failure of governance? The terms ‘success’ and ‘failure’ – and, indeed, the notions of ‘rise and fall’ – need some qualification in this context. As Malpas and Wickham point out (1995), positivist social science and twentieth-century western life more generally tended to concentrate on success and downplay failure, portraying the latter as an aberration or temporary breakdown in the governance of !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:> 42 Gísli Pálsson a social system. For them, in contrast, failure is a result of the necessary incompleteness of governance: Governance is . . . predicated on the resistance of the object, not only in terms of the being of the object as something recalcitrant, but also in terms of the object as in some sense separate from that which governs. Moreover, since every project is always a part of some more extensive assemblage, so every project is always enmeshed with other projective activities, and there can be no guarantee that such projects, though connected, will even be wholly consistent with one another. (Malpas and Wickham 1995: 46) Given such a perspective, a biobank project is necessarily incomplete, a relative failure, embedded in larger projects composed of conflicting as well as complementary components. A ‘biobank’, then, is not a pre–formed thing readily available for ‘experimenting’ but an embedded enterprise co-constructed by context. While some narratives suggest the ‘shelving’ or ‘failure’ of the Icelandic project was mainly due to legal and ethical developments (Abbot 2004; Winickoff 2006), in reality the reasons were more complex. I argue that there were many reasons for the disintegration of the Icelandic project, financial, managerial, ethical, and political. Above all, the fate of the project underlines problems in governing and the tensions of domestic as well as international bioethics and biopolitics. One of the main reasons for the disintegration of the project, I argue, has to do with what I call the ‘biopolitics of the dispossessed’, the strategies of resistance developed by segments of the Icelandic medical establishment which suddenly felt deprived of the control and security they had enjoyed in the past, threatened by the biomedical landscape fashioned by the biobank proposal. In the process of adapting to a changing scene the biobank project has been decomposed, redefined, and transformed as part of an emerging biomedical assemblage. A brief note on the setting is in order. Iceland was probably settled from Scandinavia and the British Isles during the ninth century. Soon after the settlement, a parliament al-thing or Alþing was established; thus began the general assembly of Iceland. While the Alþing is often seen as one of the earliest forms of democratic national government, this is an exaggeration (Karlsson 2000: 21). The establishment of the Alþing signified the beginning of the so-called ‘Commonwealth Period’ which gave birth to the saga literature, a unique source of information about the stateless social formation in question. Eventually, in 1262, the Commonwealth collapsed due to internal pressure. Iceland remained a colony of Norway and Denmark for centuries, until 1944. Soon after World War II, the economy was modernized and the focus of production shifted from agriculture to fishing. Due to a rapidly expanding fishing fleet, new markets for fish products abroad, and increased fishing effort by foreign fleets on Icelandic grounds, pressure on the main fishing stocks reached critical levels in the 1970s. While fishing no longer has the !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:? The rise and fall of a biobank: The case of Iceland 1111 2 3 4 5111 6 7 8 9 1011 1 2 3111 4 5 6 7 8 9 20111 1 2 3 4 5111 6 7 8 9 30111 1 2 3 4 5 6 7 8 9 40111 1 2 3 44 45111 43 dominant status it had for years, as the main source of wealth, it has continued to shape political discourse on resource management, governing, and access. The modern Icelandic state is a parliamentary democracy with a strong welfare system much like those of Scandinavia. Currently, the total population is 300,000. Political culture emphasizes individualism and personal autonomy. At the same time it emphasizes continuity with the past, particularly in terms of language. The Icelandic context, moreover, is characterized by a dynamic entrepreneurial culture. There is a general sense that energetic individuals with creative ideas are able to ‘get things done’, significantly influencing the turn of events and the shape of economy and society. Entrepreneurial dynamism probably has several roots. For one thing, the small scale of the population provides a sense of relative closeness between the grassroots and the state, commoners and the elite. Also, there is extensive social mobility and cultural homogeneity, in the absence of a traditional elite and rigid class structure. Moreover, since World War II, which brought a new scale of innovation and economic expansion to Iceland, the local population has drawn upon a range of foreign influences, from America, Scandinavia, and the rest of Europe. This mixing of different traditions in many fields, including education, research, banking, technological developments, and industries, has created a fertile soil for entrepreneurial culture. The health sector database The plan for the construction of a Health Sector Database on the Icelandic population was initiated by deCODE genetics, a company established in 1996 by two physicians, the Icelander Kári Stefánsson (a Professor at Harvard University) and his collaborator Jeff Gulcher. The plan was to use the relatively homogeneous Icelandic genome and the wealth of local historical records for the purpose of advancing biomedical research on the genetics of common diseases.1 Such an initiative has to be partly seen within the context of international developments at the turn of the century when genomics and associated technologies and bioindustries were being developed at an exponential rate, partly as a result of spectacular advances in the understanding of life and partly as a result of promises of a new gold rush. The Human Genome Project had already been launched, signalling scientific breakthroughs and a new scale of genomic enterprises. The time seemed to be ripe for large-scale enterprises bringing the dynamics of the market into population genetics, in some kind of partnership with national and international governing bodies. Not only were genomic enterprises shaped by the international scientific and economic context, also the rules of the game were increasingly being framed within the global governance and politics of bioethics. As it unfolded and eventually disintegrated, the HSD project was both informed by the global context and instrumental in its development. The local and the global mutually constituted each other. !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:: 44 Gísli Pálsson Immediately after the presentation of the first bill for the Health Sector Database to the Icelandic Parliament, there was a strong public reaction both domestically and internationally. After nine months of national debate, in December 1998 the Icelandic Alþingi passed a bill authorizing the construction of the database (Icelandic Parliament 1998, Act no. 139). Given the pioneering nature of the enterprise, a legal and ethical model or framework for such a comprehensive, national project was nonexistent. The license to construct the biobank was open to competition; the licensee would finance it, and the end result would belong to the National Health Service, with the licensee retaining privileged rights to commercialize it for twelve years. deCODE genetics was granted the license to construct the database. The text for the license specified that the company should pay the Icelandic state a certain fee for the assembly and use of the records of the medical service. deCODE genetics was requested to cover the cost of the agreement on the database, its construction, and marketing. In addition, it had to forfeit 70 million Icelandic kronur annually (about 1 million $US) for the license that would be used for furthering medical research and development. Furthermore, the Icelandic state would receive six per cent of the annual profit that deCODE genetics would make from using the database. The public debate in Iceland frequently referred simply to ‘the database issue’ (gagnagrunnsmálið ), subsuming medical records (the HSD), genetic information, and genealogies as well as their combination (see Figure 3.1). International discussion also emphasized the combination of these three datasets and their collective commodification. This is not surprising as original plans suggested combining medical records and the other two databases for scientific and commercial purposes, thereby developing a ‘genetic database’. The legal framework, however, of the Health Sector Database is exclusively focused on the assembly of medical records. Genetic samples would be collected for specific research purposes and only combined with medical records on the condition of scientific and ethical screening and approval. Genealogies in the public domain The Book of Icelanders Consumers: genealogists the internet or a CD-ROM Health-care data obtained with presumed consent Blood samples obtained with informed consent Protection of individual data by independent parties Health Sector Database Cross-matching monitored by committees on ethics and data protection Genotypic data Consumers: researchers drug companies, governments Figure 3.1 The Icelandic ‘Database’ (From Pálsson and Harðardóttir 2002) !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:! The rise and fall of a biobank: The case of Iceland 1111 2 3 4 5111 6 7 8 9 1011 1 2 3111 4 5 6 7 8 9 20111 1 2 3 4 5111 6 7 8 9 30111 1 2 3 4 5 6 7 8 9 40111 1 2 3 44 45111 45 For the spokespersons of the HSD, the power of genetic and epidemiological analyses would be greatly enhanced by the project. The medical records available since 1915, it was argued, would allow for the exploration of a set of new questions on the interaction among a number of variables apart from genetic makeup and genealogical connections, including variables pertaining to lifestyle, physical and social environments, the use of particular medicine, and degree and kind of hospitalization. A relatively homogenous population with good genealogical as well as medical records would be the ideal experimental site for biomedical analysis. According to deCODE genetics and their investors, the Icelandic context met such conditions better than most other contexts. No doubt, deCODE’s early statements about the value of biomedical research in the Icelandic context overemphasized the genetic homogeneity of Icelanders and their isolation through much of their history, partly to appeal to research funds, policy makers, and investors. Genetic analysis, however, shows that the rhetoric has more than a kernel of truth.2 There were several other kinds of motives than scientific advantage for the establishment of the HSD. While Icelandic healthcare is highly efficient, and Iceland ranks at the top internationally in terms of several measures, including longevity, it is quite expensive. From the point of view of members of Parliament, ministers and representatives of the state, the HSD would render the healthcare system more effective. Also, the database would provide a range of new jobs and firmly place Iceland in the growing new economy, an important asset in an economy heavily dependent on one kind of overexploited resource, the fisheries. From the point of view of the Icelandic medical authorities and spokespersons for deCODE genetics, the HSD, then, had clear scientific and managerial motives. Almost from the beginning, the public supported deCODE genetics and the database project. In April 2000 a Gallup survey concluded that no less than eighty–one per cent of Icelanders supported the database, while nine per cent were opposed and ten per cent were neither for nor against. One further sign of public support for the HSD was the strong positive initial response of the Icelandic stock market to deCODE genetics, although the reaction of the market later on has been mixed and shifting. deCODE genetics and the database project, supporters of the project argued, would advance biomedical research in Iceland, creating many new positions for scientists and laboratory assistants both within the company and at the University of Iceland. deCODE genetics, it was often pointed out, had attracted much investment from abroad and created numerous jobs for Icelandic scientists, many of whom in the absence of deCODE genetics would have been forced to seek employment abroad. The arguments of the proponents of the project also tended to emphasize the opportunities it provided in terms of private initiative. Furthermore, local interest in the database has to be partly seen within the context of ‘Norse’ history. The nationalist discourse of Icelanders – with its emphasis on the sagas, the glories of the past, and the ‘uniqueness’ !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:# 46 Gísli Pálsson of Icelandic heritage – partly explains the fascination of modern Icelanders with genetic databases and family histories. A strong ethical and political body – Mannvernd, the Association of Icelanders for Ethics in Science and Medicine – was formed in direct response to the database project. Its main spokespersons were physicians, biologists, geneticists, and philosophers. Analysis of newspaper articles mentioning the database project published in the heat of the debate shows that physicians wrote no fewer than twenty-eight per cent of the articles – understandably, perhaps, since they have compiled many of the medical records that are the subject of debate (Pálsson and Harðardóttir 2002). Their contributions turned out to be overwhelmingly against the project. The opposition to the project emphasized ethical concerns, particularly that of privacy, the protection of personal medical information. Another important concern for much of the opposition was that of informed consent. The HSD was to operate on the basis of the principle of presumed rather than informed consent; people could refuse to be included in the collective medical records, but if they didn’t, information on them would be automatically entered. Much of the discussion of the database project focused on issues of property and control. Thus, a fundamental debate took place concerning the ownership of and access to genetic information and medical records. Perhaps the dominant focus in the debate was the fact that a private multi-national company proposed to explore the genetic bases of common diseases in the entire Icelandic population and to commercialize its results. Some of the critical newspaper comments in this genre echoed claims about ‘biopiracy’ popular in debates on genetic research on indigenous groups and the Human Genome Diversity Project. The property issue has often been discussed with reference or in comparison to ongoing debates about another thorny common-property issue, namely, the allocation of individual transferable quotas to rights in fish. Medical (and possibly, genetic) information, it was argued, are commonpool resources with some of the characteristics of the fishing stocks in Icelandic waters. Privileged access, permanent or temporary, should therefore be granted only in return for a fee to ensure equity and fairness. For many of the critics, however, the commodification of biomedical data was problematic. The heat of the opposition to the project was driven by an apparent sense among physicians of rather suddenly lacking authority in the biomedical domain, of losing dominion over information largely constructed and controlled by them in the past. Some academics alleged that the restrictions of access to information and resources implied in the privileged contract of deCODE genetics with the Icelandic state would inevitably result in the stagnation of bioscience. Thus, the sub-text of some of the debates centered on where cutting-edge research on the Icelandic human genome occurred and where it should be located in the future. With the construction of the database, physicians and academe were being removed from the discursive center of local biomedicine, making way for state officials, database staff, and spokespersons for deCODE genetics. !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:8 The rise and fall of a biobank: The case of Iceland 1111 2 3 4 5111 6 7 8 9 1011 1 2 3111 4 5 6 7 8 9 20111 1 2 3 4 5111 6 7 8 9 30111 1 2 3 4 5 6 7 8 9 40111 1 2 3 44 45111 47 The biopolitics of the dispossessed When it was launched, the HSD was presented as a fundamentally new avenue to biomedicine, drawing upon the successes of the new genetics and the dynamics of the market. About twenty-five people worked full-time on the project for over two years doing preparatory work. Precursory computer programs were developed and tested. A prototype was prepared, a ‘container’ into which the data would be fed once everything was clear. In addition, a pilot project involving the healthcare institute of the town of Húsavík in northern Iceland was set up to explore some of the problems involved. Moreover, ethical and legal frameworks were discussed and revised. In the process of preparing all of this, deCODE staff would tour the country, visit health clinics, and introduce their project to local leaders. More than fifty institutions throughout the country had to be consulted. Despite all of this diplomatic effort, the project came to a halt. Most of the key people associated with it seem to assume that it is no longer on the agenda although the death certificate has so far not been issued in public. Given the buzz surrounding the plan for the biobank, the first of its kind, one is entitled to ask why it hasn’t materialized. Interviews with some of the people working on the construction of the database revealed important reasons and concerns. Several kinds of problems emerged and caused delay. Some of the difficulties encountered by the deCODE team were purely technical ones. Digitalizing and assembling massive amounts of data from different periods and different healthcare institutes demanded extensive work on software development and the standardizing of criteria to be applied in the entry of data. This probably proved more complex and time consuming than anticipated. Relations with the local communities involved were also problematic at times. In many cases, there were demands for some kind of rewards, in particular new jobs, involving local people in the digitalization of medical records, a massive corpus of information that had accumulated in paper form for decades. A further reason for slow-down relates to what might be identified as the biopolitics of the dispossessed. The HSD would only become useful if records from local clinics were passed on to the licensee for assembly. The Icelandic Medical Association, however, claimed from the beginning that the database would violate the relation of trust between physician and patient, since it would operate on the basis of the principle of presumed consent, thereby violating the standard practice of informed consent. As the database was under construction, some directors of local clinics refused to hand over ‘their’ records, emphasizing their responsibility to their patients and pointing out that the latter had not consented to any such transfer of information about them. The main organized opposition to the project, the Association of Icelanders for Ethics in Science and Medicine, supported their refusal to hand over local records. Some patient groups complained that the doctors were not consulting patients and that they had no right to make decisions !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:7 48 Gísli Pálsson about medical records on their behalf. In effect, they argued, the doctors were claiming ownership and control of information that properly belonged to both the patients themselves and the community – the Icelandic state that had financed their recording and assembly. Inevitably, the opposition of the Medical Association slowed things down. While many of the necessary preparations for the HSD had been made, contracts with local clinics were not signed because of professional resistance. Sometimes the only local physician was passionately opposed to the project and local people felt obliged to proceed carefully and to avoid confronting them, commenting ‘they didn’t want to lose their doctor’. In some cases, medical data were not passed on despite the fact that clinics had signed the relevant agreement. Sometimes, the records for an entire town had to be ‘abandoned’ due to physicians’ resistance; one key physician in a fishing community insisted that ‘his’ data would not be transferred: ‘over my dead body!’ In another case, every time the deCODE staff would arrive for discussions the local physician would disappear from the scene with some kind of excuse. While the preparation and handing over of local health records would present some burden to local clinics in terms of time and resources, deCODE staff were taken by surprise by the resistance. Why would local data not be almost automatically passed on to the makers of the database, given that the authorities in question, Parliament and the Ministry for Health, had decide to get this done and to offer the licence and the responsibility to deCODE? One stumbling block in the making of the database project was the fact that a growing number of people opted out of it, refusing to pass on their personal information. By June 2003, roughly 20,000 people had opted out, a significant figure given the size of the population. A further setback was a decision by the Supreme Court in November 2003. The case, Ms. Ragnhildur Guðmundsdóttir vs. the Icelandic State, centered on the legality of presumed consent with respect to medical information regarding children, incompetent adults, and the deceased (Supreme Court of Iceland 2003, no. 151). Ms. Guðmundsdóttir protested against the transfer of data pertaining to her deceased father to the database. Would it be meaningful to apply the principle of presumed consent to people who were not in a position to opt out of the database? The Court acknowledged the rights of relatives of deceased persons to make decisions about the data involved, thereby adding one more complication to the database project. An important problem related to the security targets set by the Office for Personal Data Protection. deCODE staff suggest the targets set for protecting the anonymity of samples and data were both too high and too cumbersome to work with. A tight ‘wall’ or ‘curtain’ was established between the researcher and the data for protection against potential ‘malicious users’, making meaningful work on the data nearly impossible. This was partly the result of miscommunication between two groups with rather different training and perspectives: deCODE scientists and state lawyers. The Office for Personal !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$:5 The rise and fall of a biobank: The case of Iceland 1111 2 3 4 5111 6 7 8 9 1011 1 2 3111 4 5 6 7 8 9 20111 1 2 3 4 5111 6 7 8 9 30111 1 2 3 4 5 6 7 8 9 40111 1 2 3 44 45111 49 Data Protection suggested a ‘veil’ or ‘curtain’ between the researchers and the raw medical data. This put heavy constraints on the project. As one of the deCODE staff commented: Usually when I work with health records . . . I operate with some kind of matrix with a host of variables such as age, the use of medicine, blood pressure etc. I can scan all the lines and quickly spot some of the obvious errors there may be. Now I couldn’t do this. The staff of the Office for Personal Data Protection were so scared of the possibility that we might recognize the individuals in question. They felt they had to change the averages a bit by means of some kind of algorithm; otherwise, they reasoned, everything might be traceable. As a result, we had to fumble about in the dark. Negotiations about security targets got increasingly strained. The running of the HSD could only begin once the Office would be satisfied with the security measures employed. deCODE complained with the analogy of building a hydroelectric power plant, a pertinent analogy in the Icelandic context. Would it make sense to invest in a massive project like that under the uncertainty that for some reasons channelling water to the turbines might not be permitted once the plant had been completed? No one, it was reasoned, would agree to take such risks. In effect, the Office for Personal Data Protection functioned as an ethical supreme court, with a final word in the screening process and no possibility of appeal. The Icelandic debate was not a closed national case. The international press, the trans-national scientific community, and the emerging informal, international network of bioethicists were heavily focused on the HSD. Part of the reason why the Icelandic case was frequently reported had something to do with the somewhat risky but skilful handling by deCODE genetics of public relations, including its frequent reference to genetic ‘roots’ and the ‘Viking’ past. Icelanders were pictured as the guinea pigs of the new genetics, equivalent to model organisms such as the fruit fly. ‘Expert’ witnesses from the trans-national world of science and bioethics often addressed the key issues internationally at conferences, in the media, and on the web (see, for instance, Rose 2003). The Icelandic plans were fiercely opposed, usually from a bioethical vantage point emphasizing patients’ rights, informed consent, and the protection of privacy. The response of the international press and academe partly reflected a growing competition between similar projects on the global scene. Recently, Francis Collins, the director of the US National Human Genome Research Institute, suggested, drawing attention to biobank projects proposed or underway in the United Kingdom, Iceland, Estonia, and Japan, that the United States could ill afford not to invest in its own populationbased cohort study. An economic backlash experienced by deCODE at a critical moment had important implications for the database project. The company was forced to !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$!" 50 Gísli Pálsson make about one-third of its personnel redundant. In an attempt to make ends meet, it streamlined its research on patient groups and increasingly moved into drug discovery and development. At the same time, work on the HSD project was slowed down. The financial backlash at deCODE was partly the result of an international backlash in bioindustries which, in turn, was partly a consequence of debates about the human genome projects. For some time there was an intense tug-of-war between the communitarian and private perspectives represented by the public genome project and the company Celera. Did the human genome belong to humanity or was it up for enclosure by private interests and industry much like the high seas many years ago?3 Billions of dollars were drained from the biotech sector, more than $2 billion from Celera alone (Shreeve 2004: 324). Stock prizes on the Nasdaq exchange collapsed, with serious consequences for many biotech companies throughout the globe. Some genetic database projects were slowed down or scrapped, testifying to the global nature and implications of developments in biotechnology and biomedicine. Some of those interviewed experienced a growing disillusion inside deCODE genetics with the database project. One scientist, a former employee of the company commented: ‘I was hired when the project began. Then, in 2002 I sensed that something was brewing. I lost faith in what I was doing, thinking “this will never be realized”. I was moved to another task, to a patient-group project. This was what the company got payments for. Soon after, I applied for a job elsewhere.’ Faced with increasingly winding and time-consuming negotiations and legal battles, rising costs, and growing economic difficulties in the biotech industry, deCODE genetics may have decided to back off and resort to an alternative strategy, expanding its own internal patient-group database and escalating its work on drug development. Currently, the company has acquired genetic samples from about half of the adult Icelandic population through its work on specific common diseases. Despite the shelving of the database project, it has made important advances in genetic research through conventional avenues more or less independent of the biobank enterprise. Perhaps the most impressive achievement of deCODE is a recent clinical trial involving the risk of myocardial infarction. An editorial in the Journal of the American Medical Association suggested that while the trial, ‘one of the first human trials to attempt to translate genomic findings into clinical practice for cardiovascular disease’, should be viewed as preliminary it ‘provides an exciting attempt to translate genetic findings to clinical applications’ (O’Donnell 2005: 2278). Results like these may have important practical implications, paving the way to diagnostic tests to identify people carrying the variant genes, preventive measures in terms of lifestyle, gene therapy (a particularly controversial procedure), and, possibly, the development of drugs that affect expressions of the proteins involved. The health authorities and the state may also have decided to define their own alternatives to the HSD although officially they may still be committed to it, developing scattered databases and collections which might later on !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$!4 The rise and fall of a biobank: The case of Iceland 1111 2 3 4 5111 6 7 8 9 1011 1 2 3111 4 5 6 7 8 9 20111 1 2 3 4 5111 6 7 8 9 30111 1 2 3 4 5 6 7 8 9 40111 1 2 3 44 45111 51 be somehow combined. From now on, medical records are stored in digital form in the clinics of the National Health Service where they materialize, forming a potential future database that might eventually be combined with the records of the past. Also, a centralized database on medical prescriptions and drug use is already in existence. Finally, one of the spin-offs of the database project is the genealogical Book of Icelanders, which has proved quite useful in deCODE’s research on patient groups. Discussion While biobanks differ in several respects, they all represent the extension of the biomedical gaze. As Lyotard points out, data banks are ‘the Encyclopedia of tomorrow. They transcend the capacity of each of their users. They are “nature” for postmodern man’ (1984: 51). Some of the important early biopolitical developments that pre–date biobanks relate to practices of writing, tabulating, and computing. In Medieval Europe, bioinformatics focused on documenting births, deaths, and marriages. During the nineteenth century, statistics and probabilistic methods were developed to describe the health risks and tendencies of national populations and their subdivisions. Adopted in one nation state after another, they represented concerns with keeping track of the health of the general public and governing the national body. Hacking suggests, however, that the ‘avalanche in numbers’ that was generated in the process was rarely efficient in managing the population of study: ‘The fetishistic collection of overt statistical data about populations has as its motto “information and control,” but it would more truly be “disinformation and mismanagement”’ (1982: 280). In his view, on the other hand, the new ‘statistics of sickness’ had subversive effects, namely ‘to create new categories into which people had to fall, and so to create and to render rigid new conceptualizations of the human being’ (1982: 281). While the eighteenth and nineteenth centuries gave birth to biopolitics, the politicization of bare life was taken to its extremes during the twentieth century.4 The dark shadow of concentration camps and the eugenics that often comes with them continues to inform, and to misinform, discussions of biopolitics, including biobanks. Hacking’s argument (1982) about the fetishism of numbers and disinformation in the collection of statistical data about populations may not be entirely valid for the kind of population biobanks discussed here. After all, they are likely to be efficient biomedical tools, speeding up analyses of the distribution and causes of common diseases. Nevertheless, Hacking’s point draws attention to the different and somewhat contradictory agendas of biopolitics (of governments, politicians, companies, etc.), unexpected developments, redefined agendas, indirect spin-offs, and the potential clash between promises and results characteristic for the genome era (see, for instance, Taussig 2005, Lock 2005). In a sense, the Health Sector Database has been decomposed, much like a fragmented human body, recombining with other projects serving different times and agendas. Quite possibly, in the future !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$!> 52 Gísli Pálsson large-scale genetic databases will be operative at numerous sites, either permanently or from time to time. For gaining larger numbers and samples, which may be important for analyzing many common diseases, different database projects may find it feasible to temporarily share data under some kind of permanent institutional umbrella. Database projects are not just innovative technical, scientific, and economic enterprises; they are radical experiments in biopolitics with potentially diverse social implications for individuals, families, communities, and the public at large. The broad responses by the international community to such experiments, however, vary from one case to another (Pálsson and Rabinow 2005). No doubt, there are several reasons why the Icelandic case was particularly contested. One important reason probably relates to the fact that the population of an entire nation was involved, not a sample. Many critics found such an inclusive approach shocking, evoking an image of a totalitarian, if not eugenic, regime. I have argued that the main reason for the disintegration of the HSD project has to do with the resistance of local physicians, the biopolitics of the dispossessed. This, in turn, was heavily informed by bioethics on both the local and the global scene, as it grappled to deal with the developments of the genome era partly through its discourse on informed consent. The rapid expansion of bioethics during the second half of the last century need not be surprising. By definition, the emergence of the new genetics invited concerns with both individual liberties and the collective rights and responsibilities of nations, populations, and ethnic groups. A growing governmentality literature explores how certain phenomena become formulated as problems, ‘investigating the sites where these problems are given form and the various authorities accountable for vocalizing them’ (Xavier Inda 2005: 8).5 Interestingly, in the past decade or so, bioethics seems to have taken a communitarian turn, shifting from the perspective of the autonomous individual and the heavy reliance on informed consent which it has advocated in the recent past to a more holistic perspective, emphasizing the principles of reciprocity, mutuality, solidarity, citizenry, and universality. Knoppers and Chadwick suggest that a new ‘participatory approach’ has emerged as a result of the growing influence of social science on ethics and the reinterpretation of the concept of ‘expertise’ in genetic ethics. ‘There might not’, they conclude, ‘and cannot, be universal norms in bioethics, as emerging ethical norms are as “epigenetic” as the science they circumscribe’ (2005: 78). Thus the principle of informed consent that was at the center of the storm around genetic databases early on has been losing ground. Some ethnographic evidence indicates that bioethical practice may not have the same meaning to bioethicists and the ‘lay’ people they claim to speak for. Thus, Almarsdóttir, Morgall Traulsen, and Björnsdóttir (2004) suggest, on the basis of focus group discussions in the Icelandic context, that the issues of confidentiality, privacy, and data protection tend to be framed in a fashion that is rather different from the perspective of personal autonomy prescribed by orthodox bioethics. !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$!? The rise and fall of a biobank: The case of Iceland 1111 2 3 4 5111 6 7 8 9 1011 1 2 3111 4 5 6 7 8 9 20111 1 2 3 4 5111 6 7 8 9 30111 1 2 3 4 5 6 7 8 9 40111 1 2 3 44 45111 53 It is notoriously difficult to draw lessons from a single case. While Iceland is a welfare state that shares many of the characteristics of other contexts, including Scandinavia, the Icelandic context is somewhat unique, with its nationalistic rhetoric and its emphasis on ancient roots and entrepreneurial dynamism. Each biobank enterprise has a path-dependency of its own, defined by the initial conditions of its making and the evolving context of which it is a part. Had the Icelandic project been launched from the beginning as a truly collaborative venture between academe, government and industry, its life course might have been entirely different – and the strategies of resistance might not have emerged or taken a radically different shape. Had the original plan underlined informed rather than presumed consent, the concern with security targets would perhaps have been less overwhelming and the slowdown, perhaps, would have been less effective. Had the ‘communitarian turn’ in bioethics taken place prior to the launching of the HSD, the Icelandic controversy might never have taken off. Had the economic backlash experienced by the biotech industry occurred a few years later, deCODE might not have shifted its course. And so on. Historical speculations along these lines, with unreal past conditional clauses, are not particularly fruitful. In the unfolding of the Icelandic case, the politics of biobanking and the HSD were co-constructed, mutually informing each other and similar biobank enterprises later developed in other contexts. As Winickoff observes, the Icelandic Health Sector Database became an experimental site for genomics and genomic governance in the sense that it ‘helped produce the technological, political, and normative terrain of all large-scale genomics initiatives today, not just Iceland’s’ (2006: 97). Acknowledgements The research on which this article is based was generously funded by the Nordic Committee for Social Science Research (NOS-S), the Icelandic Center for Research (Rannís), and the Research Fund of the University of Iceland. I thank Dr. Anna Birna Almarsdóttir, Valgerður Gunnarsdóttir, and Kristín Erla Harðardóttir for their suggestions and remarks regarding some of the issues discussed here. Also, I appreciate comments on an early draft by other contributors to this book, in particular the editors. Notes 1 The idea of constructing a comprehensive population database on Icelanders was not a novel one. In an essay written in 1943, the novelist Halldór Laxness suggested that an ‘anthropological’ office or institute (mannfræðistofnun) be established in order to document, for the purpose of marketing and research, information on every Icelander ever recorded: ‘Information on every family would be organized (kerfaðar) so that the employees of the institute would be able to assemble, at short notice, the family history of any Icelander . . .’ (Laxness 1962: 155–6). A precursor to the Health Sector Database was a database made from the early !"##$%&'%()*+$(,-./0123$$45646"7$$489:5$$;<=.$!: 54 Gísli Pálsson 1960s onward under the umbrella of the University of Iceland and largely funded by the Atomic Energy Commission of the United States. In 1966, a Genetic Committee was established at the University of Iceland, the role of which was to encourage and organize genetic research at the University and, more generally, in Iceland (see Pálsson 2007). A recent study, by deCODE researchers, suggests the ‘overwhelming conclusion . . . is that the Icelandic gene pool is less heterogeneous than that of most other European populations’ (Helgason et al. 2003: 283). A review of the literature of human genetic diversity in Europe supports such a conclusion, arguing that ‘Icelanders do show evidence of greater drift effects than most other European populations’ (Barbujani and Goldstein 2004: 138). Attempts were being made to reconcile the plans and interests of the two projects, but negotiations repeatedly collapsed. In March 2000, US President Bill Clinton and Prime Minister of Great Britain Tony Blair issued a joint statement in an attempt to bring things under control, urging nations, scientists, and corporations to freely share their information. The effect of this statement was immense. The extreme case is represented by the formation of concentration camps by the German Social-Democratic government in the 1920s and later on during the Nazi regime. For Agamben, the camp is ‘the hidden matrix and nomos of the political space in which we are still living’ (Agamben 1995: 166), a space characterized by the politicization of bare life, the new biopolitical body of humanity. Maskell and Pelts criticize the conception of ethics that ‘turns the ethical code into a kind of “constitution” . . . and the professional into an adjudicator who, on the basis of this ethical constitution and his mastery of expert information, assumes a position of unquestioned (and often implicit) superiority’ (2005: 3). For them, it is essential to ‘embed’ ethics, to locate ethics not in a law-like universal or a ready-made scheme but in practices of interaction. 2. 3. 4. 5. References Abbot, Alison (2004) ‘Icelandic database shelved as court judges in peril’, Nature, 429 (13 May): 118. 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