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Promising pessimism: Reading the futures to be avoided in biotech

Richard Tutton Social Studies of Science 2011 41: 411 originally published online 21 February 2011 DOI: 10.1177/0306312710397398 The online version of this article can be found at: http://sss.sagepub.com/content/41/3/411 Published by:
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Promising pessimism: Reading the futures to be avoided in biotech

Richard Tutton

Social Studies of Science 41(3) 411429 The Author(s) 2011 Reprints and permission: sagepub. co.uk/journalsPermissions.nav DOI: 10.1177/0306312710397398 sss.sagepub.com

ESRC Centre for Economic and Social Aspects of Genomics (Cesagen), Department of Sociology, Lancaster University, Lancaster, UK

Abstract
A number of science and technology studies (STS) scholars have suggested that the performativity of the forward-looking statement is an important institutional element of contemporary biocapital. This paper considers how, when making projections that set up expectations about their futures, firms also acknowledge and detail the risk factors that they face in their operations. In other words, in addition to projecting optimistic scenarios, firms advance much more pessimistic images of futures that they wish to avoid: possible failures, disappointments and financial losses. I examine such pessimistic projections in company filings to the US Securities and Exchange Commission (SEC) and investigate their discursive character. I ask what value such pessimism might hold for STS scholars interested in the mangle of science and capital. I sample the SEC filings of three companies: deCODE Genetics, DNAPrint Genomics Inc. and NitroMed Inc. In their own particular ways, these projections exemplify the volatility and the promise of the life sciences in the 21st century. My reading shows that such pessimistic risk factor statements provide interesting commentary on the dynamics of risk and innovation in the context of contemporary biocapital, raising questions to which analysts to date have given little attention.

Keywords
anticipation, biocapital, futures, promise, sociology of expectations

STS studies on the contemporary mangle of science and business increasingly treat the dynamics of hope, anticipation, vision, promise and expectation as central to understanding political economy (Fortun, 2008; Shapin, 2008; Sunder Rajan, 2006; Thacker, 2005; Thompson, 2005). Moreover, work in the sociology of expectations has argued that expectations and other such creatures of the future tense (Selin, 2008) are performative:
Corresponding author: Richard Tutton, Department of Sociology, ESRC Centre for Economic and Social Aspects of Genomics (Cesagen), Lancaster University, Lancaster LA1 4YD, UK. Email r.tutton@lancaster.ac.uk

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that is, anticipation itself constitutes economic and epistemic value, and speculative claims are fundamental to the dynamic processes that create new socio-technical networks (Brown et al., 2000; Hedgecoe and Martin, 2003). This paper takes its point of departure from such work but is specifically concerned with the role of pessimism in the dynamics of the promissory economy in contemporary biotechnology, a field that typically projects a positive future in which new biological knowledge will transform human health and behaviour through developments such as personalized medicine. In light of the financial crisis of the past few years, pessimism has gained prominence in popular debates about economics and politics. Towards the end of 2009, a New York Times article suggested that venture capitalists should be renamed venture pessimists, given their apparent reluctance to invest in innovative, high-risk start-ups (Miller, 2009). The long association between pessimism and conservative politics also continued with John Derbyshires (2009) recent book, We Are Doomed, which juxtaposes Barack Obamas audacity of hope against his own (perhaps ironic) audacity of hopelessness. In the biotech sector as well, the filing for chapter 11 bankruptcy by deCODE Genetics in 2009 once the most bullish of genomics companies led to some pessimistic commentaries suggesting that the gene revolution was now over (Matthews, 2009). Of course, every future is predicated on others to be avoided. In parallel with positive visions and hopes of future advancements, fears and tenebrous imaginings of future risk are often associated with scientific and technological change. Such dark imaginaries have provided the material of science fiction for more than a century. Futures are contested, whether conjured as visions of utopia or dystopia. In this paper, I consider the significance of the forward-looking statement in order to explore and understand the role of pessimism in contemporary debates about biotechnology. In doing so, I examine the relationship between promising and pessimistic futures constructed in company filings to the US Securities and Exchange Commission (SEC). The discursive character of this pessimism, I argue, should interest social scientists who study the mangle (Pickering, 1995) of science and capital in the 21st century. To frame this analysis, I begin by considering how social scientists thus far have thought about forms of futuremaking in the area of biotechnology.

Sociologies of futures, promises and expectations

In Cynthia Selins (2008) words, those creatures of the future tense promise, expectation, speculation, vision, hope, prophecy and anticipation have become the subject of analysis across the field of STS in the past two decades. Such analysis borrows upon but also diverges from earlier work such as Robert Mertons (1948) on self-fulfilling prophecies. The sociology of expectations that emerged in Europe in the late 1990s has had growing influence on studies of scientific, technological and economic innovation (Borup et al., 2006; Brown et al., 2000). Studies of the life sciences have investigated the role of expectations in xenotransplantation (Brown and Michael, 2003), stem cell research (Martin et al., 2008), regenerative medicine (Wainwright et al., 2008), biobanking (Tutton, 2007), pharmacogenetics (Hedgecoe and Martin, 2003), pharmaceuticals (Williams et al., 2008) and anti-ageing medicine (Mykytyn, 2010). The sociology of expectations approach differs from the realist orientation of economic models of

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expectations that sought to distinguish between actors expectations of the future and the actual prospects of an innovative programme (with the gap between them being consigned to hype). The sociology of expectations takes the position that it is impossible to step outside of expectations to determine the real value of some new and yet untested technology. Accordingly, we should understand expectations to be first and foremost constitutive or performative in attracting the interest of necessary allies (various actors in innovation networks, investors, regulatory actors, users and so on) and in defining roles and in building mutually binding obligations and agendas (Borup et al., 2006: 289). Expectations can therefore be understood as wishful enactments of (rather than wishful thinking about) desired futures, which have a vital relational quality, brokering relationships between actors so that expectations can become mutually shared guides for action. As Hedgecoe and Martin (2003: 329) observe, understanding the formation, mobilization and shape of these expectations or visions is therefore central to the analysis of an emerging biotechnology. Expectation is not the only concept of future imaginings in social studies of biotechnology or biomedicine. Related notions of promise or the promissory have been developed, mainly but not exclusively by North American scholars (Fortun, 2001, 2005, 2008; Sunder Rajan, 2006; Thompson, 2005). Charis Thompson uses the term promissory capital to describe the biomedical mode of reproduction through which bodily tissues and organs obtain value in systems of exchange for their potential uses. She suggests that capital should be understood less in terms of classic notions of accumulation in industrial capitalism and more as constitutively promissory because their value unfolds over time (Thompson, 2005: 258). Sunder Rajan (2006: 136) develops the idea of biocapital to investigate the contemporary implosion of science and capitalism that he calls, using Joseph Dumits (2003) expression, venture science that is engaged in the simultaneous production of scientific fact and capitalistic value. Venture science is promissory, risky and defined by vision and hype. To generate value in the name of realizing a promised future, venture science sells that vision even if as is often the case this is never materialized as sold. The notion of promise is also taken up by Michael Fortun (2001, 2005, 2008) in his study of deCODE Genetics and the controversy that surrounded the Icelandic Health Sector Database a decade ago. A promise, he observes, tends to be ascribed to an utterance of the form I promise, a binding contract about a future made by one person to another. In practice, however, promises are volatile and diffuse, spanning different spaces, different temporalities and different entities. Not only can an individual make a promise to a recipient, she or he also can declare that a thing is promising. Fortun concludes that: promising cannot be reduced to empty hype, or to a formal contract, but occupies the uncertain, difficult space in between (Fortun, 2005: 158). North American scholars have emphasized promise rather than expectation as the key concept in their work on the dynamics of future-making. The different analytical purchase provided by these concepts is beyond the scope of the present paper, but is the subject of ongoing work on the role of various imaginaries in STS scholarship on science, technology and capital (McNeil et al., 2010). Investors, scientists or politicians are far from the only types of people engaged in work of future-making; as a number of authors have shown, patients with incurable or chronic diseases and their relatives also mobilize around hopes (and sometimes

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promises) of a future in which new treatments and cures will be available (Epstein, 1996; Gibbon, 2007; Novas, 2006; Rapp, 2000). Carlos Novas (2006) frames such situations in terms of the political economy of hope. Disease advocacy organizations work to translate individual experiences of disease into collective, political projects that can, when successful, (re)shape scientific research priorities and practices, direct the allocation of public resources, and gain representation on policy-making or advisory bodies. Hopes like expectations and promises are relational: they bind people together in situations that are often marked by desperation and enrol them in aspirations for a future that is open and not inevitable. The affective dimensions of futurity invoked by hope are also explored by Adams et al. (2009) with their notion of anticipation. What they call the breathless futurology of biotech involves both a politics of affect related to the hopes and desires of people seeking clinical cures and speculative epistemologies about new knowledge and technologies. They claim that anticipation has become a common, lived affect-state of daily life, shaping regimes of self, health and spirituality (Adams et al., 2009: 247); it has become a hegemonic formation that extends into many arenas of social life. Anticipation has become an episteme characterized by several forms of moral responsibility: to anticipate, be informed about and stand ready for the future(s); to make choices about divergent courses of action in the face of imperfect knowledge; to secure the best possible futures for oneself; and to anticipate new domains in which, for example, to leverage value from existing resources.

Accountability, disappointment and pessimism

Accountability is a major theme that runs through all of the social studies of expectations, promises, visions, hope and anticipation discussed above. If we cannot step outside the conceptions and practices we study, how do we hold expectations and promises articulated by scientists and others to account? How do we decide whether the hopes of advocacy organizations acting in the name of the terminally ill for a future cure are realistic or not? Can we ourselves anticipate whether or not a particular anticipation of a future is warranted? As Borup et al. (2006) acknowledge, the articulation of an expectation does not automatically produce accountability. However, it can prompt challenges from others, who call for accountability. Some social scientists have themselves insisted on such accountability, in critical studies of what they see as the unrealistic expectations promoted by specific actors in the innovation process who make grand claims about the revolutionary impact of biotechnology (Hopkins et al., 2007; Nightingale and Martin, 2004). Nightingale and Martin (2004: 568), for instance, argue that some government and industry agents have exaggerated the speed of innovation in biotechnology, leading to poor investment decisions, misplaced hope, and distorted priorities. These critics do not step outside the anticipatory regimes of biotechnology but instead operate within them in an effort to retune the expectations at play in relation to emerging materialities. What is the purpose of these attempts to hold to account the ways in which futures are presented in the here and now? Is it to avoid disappointment and what Nightingale and Martin call misplaced hope?

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I ask these questions because it would seem that disappointment, failure to live up to expectations and to fulfil promises, and the possibility that hopes will remain unrealized (but not necessarily dashed) should always be anticipated. As Borup et al. (2006: 295) acknowledge, we should always expect that the future will underperform. This raises a number of issues: first, and this is where the sociology of expectations departs from the work of Robert Merton (1948) on self-fulfilling prophecies, it is not the case, as Pollock and Williams (2010: 5) observe, that any vision, if handled and communicated by enough reliable actors, could become true. The challenge to scholars, Pollock and Williams rightly note, is to understand why some expectations materialize and others do not an understanding that would benefit from considering different forms of performativity (see for example, Mackenzie (2006) and Callon (1998)). It also shows that disappointment is integral to the way that expectations work in science and technology, prompting the question of how disappointments or past failures are negotiated, accounted for and managed in ways that can sometimes shape new cycles of expectations (Arribas-Ayllon et al., 2010). As Borup et al. (2006: 290) note, while failure comes at a price in lost investment, energy and time, in practice it remains difficult to see whether this time our high expectations might be justifiably warranted. In some areas of sociotechnical life, however, such as warfare or efforts to preserve the natural environment, pessimism about the future has been pronounced. In Technology, Pessimism and Postmodernism, Leo Marx argues that:
The Wests dominant belief system turned on the idea of technical innovation as a primary agent of progress [however] more and more people in the advanced societies have had to consider the possibility that the progressive agenda, with its promise of limitless growth and a continuing improvement in the conditions of life for everyone, has not been, and perhaps never will be realised. The sudden dashing of these hopes surely accounts for much of todays widespread technological pessimism. (Marx, 1994:13)

For Marx, this pessimism primarily centres not on advances in the biomedical life sciences but on the technologies of war and on concerns about environmental degradation. With the prospect of peak oil, widespread deforestation, destruction of animal species, pollution of water courses, drought, and rising carbon emissions leading to a forecasted future of rising temperatures and climatic volatility, such pessimism is hardly surprising. Yet in the face of such scenarios, old promises can be revived, such as nuclear power, and new ones developed, such as carbon capture, with the aim of changing predicted futures. However, it is beyond the scope of this paper to take in the different promissory and pessimistic dynamics at work in such divergent areas of science and technology. With reference to the context of the biomedical life sciences, this paper is concerned with how futures are made in the present and the relationship between promise and pessimism in this future-making. An ideal site for this analysis is the institutional framework of the forward-looking statement, a particular regulatory instrument of corporate governance in the US that both enables inscriptions of futures and governs those inscriptions according to certain rules of discourse. Scholars such as Sunder Rajan (2006) and Shapin (2008) have identified this framework as being an important promissory element in contemporary biocapital. In what follows, I outline the history of how this framework

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came to be established in the US and discuss some of its salient features before considering in more detail how, in this framework, pessimism plays an important part in making possible the inscription of promissory futures.

Safe harbours, speculation and disclosure

Along with those of companies operating in other sectors, forward-looking statements in press releases, public speeches, other promotional materials and registration documents made by genomics and biotechnology firms registered with the US Securities and Exchange Commission are legally protected. Such protection is granted by the Private Securities Litigation Reform Act passed by the US Congress in 1995 (Pub. L. 104-67, 109 Stat. 737), which sought to prevent abusive litigation against firms by investors or their representatives in response to losses due to falling share prices (Johnson et al., 2001). The 1995 Act marked a significant departure for the SEC, which was founded shortly after the Wall Street crash of 1929 to restore investor confidence with regulations that emphasized honest and what today would be called transparent communications by firms (Securities and Exchange Commission, 2010). Given its view that the Crash was caused by heady speculation and easy credit, the SEC prohibited firms from issuing forward-looking statements because such statements were deemed unreliable as sources of unfounded speculation that could bring about another market crash (Fortun, 2008). In 1979, the SEC revisited the issue and originated the concept of the safe harbour for firms to make forward-looking statements that had a reasonable basis and were articulated in good faith (Johnson et al., 2001). However, without legal protection against possible litigation, companies appeared reluctant to provide prospective information such as forecasts of future earnings. In 1991, the US Congress began working on this matter and the legislation took shape over the next 4 years. The bill was passed by the House of Representatives and the Senate, and although President Bill Clinton vetoed it, Congress overrode his veto in late December 1995 (Spiess and Tkac, 1997). The Act therefore was controversial and debate among academics in business and law schools has continued about its implications for investors, companies and public confidence (Perino, 2003; Pritchard and Sale, 2005). The Act legally protects companies to make certain forward-looking statements (in either written or spoken form) by providing a statutory safe harbour, as long as such statements meet two criteria: first, that they are clearly identified as forward-looking, and, second, that they are accompanied by meaningful cautionary language identifying important factors that could cause actual results to differ from those projected (Johnson et al., 2001). Therefore, companies use a particular vocabulary to highlight that their press releases contain forward-looking statements. For example, a press release issued by deCODE Genetics Inc. in 2009 noted that:
These statements refer to future events or our future financial performance. In some cases, forward-looking statements can be identified by terminology such as may, should, could, expect, plan, anticipate, believe, estimate, predict, intend, potential, or continue or the negative of such terms or other comparable terminology. These statements are only expectations.1

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For Sunder Rajan and Fortun, this legislation and its provision of the statutory safe harbour for the articulation of forward-looking statements is an important element in the story of contemporary biocaptialism. Sunder Rajan sees the forward-looking statement as one of the key sites where visions are performed. As he notes, promissory conjuration is a constitutive part of the lives of all technology companies (Sunder Rajan, 2006: 129), but compared with other industries, the development pipeline in biotech tends to be a long one, often taking a decade or more, as a significant proportion of their lives and histories are stories of these companies having to sell visions of their future products as much as or more than selling the products themselves (Sunder Rajan, 2006: 12930). They are story stocks whose value is dependent, as Fortun (2001: 145) notes, not only on genetic technologies but on that other set of technologies for simultaneously producing and evaluating anticipated, contingent futures: literary technologies. The second part of granting such protection is that companies must describe risk factors that might shape the future state of affairs in a different way from that set forth in press releases and other promotional material. In the text accompanying the same deCODE Genetics press release quoted above, we find the following:
These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results, and the timing of events, to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, the effect of a potential delisting of our common stock from The Nasdaq Capital Market, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODEs filings with the Securities and Exchange Commission.2

In such texts, firms must consider all of the things that can and do go wrong. As Shapin (2008) relates, the Act absolutely requires entrepreneurs to use deflationary boilerplate language language that so severely qualifies the truth of technical and commercial claims that these mandated disclaimers are much more sceptical than anything that could be said by an external critic (Shapin 2008: 290, emphasis in original). Fortun makes the wry observation that genomics companies are compelled to partake in speculative genomic pessimism. The passage quoted above is just a sample of the often long and detailed text that composes the risk factors section of the SEC forms that firms are required to complete when undertaking a public offering (the S-1 form), or reporting on a quarterly (10-Q form) or annual basis (10-K form). On the S-1 form, the risk factors section follows immediately after the prospectus and typically is arranged under a series of sub-headings. As with the positive forward-looking statements just discussed, these pessimistic counterparts can also be identified by their own distinctive phraseology as this sample from a number of filings indicates:

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Subject to uncertainty, we cannot predict, may have adverse effect, we cannot be certain, subject to the risks of failure, there can be no assurance, our stock price may decline, it will be years, if ever, we could fail.

Considerable labour must go into writing such pessimistic textsat least as much as goes into crafting ebullient press releases. Consequently, specialist companies have made promises to service firms and their legal teams to speed up the process of completing documents and ensuring compliance. One of these companies, Intelligize Inc. based in New York, gives the following pitch:
In todays challenging regulatory climate, the cost and complexity of preparing large and unwieldy documents for SEC filing is rising. When its time to write or update SEC forms, the best practice is to draw from previous documents and passages as reference points to properly and carefully disclose information to investors and regulators.3

Shapins comments about boilerplating are borne out by the way that Intelligize operates: it has developed what it calls a precedent check application, which analyses thousands of SEC 10-K forms and identifies the most commonly used risk factors. For example, the top five risk factors found in forms filed over a 6-month period in 2009 are: failure to compete successfully (73%); general economic conditions (57%); dependence on management team (47%); difficulty of raising capital (46%); and potential share price volatility (43%). On the basis of such analysis, Intelligize seeks to identify what it calls market standards to which firms should conform when disclosing to investors and regulators the risk factors they face in their markets. Adopting these standards aims to ensure fast and uncomplicated compliance with the SEC. Through boilerplating and standardization, the articulation of risk therefore becomes a generic rather than singular quality: one that the firm shares with its competitors. One effect of the Private Securities Litigation Act is that the failure to fulfil promises or to meet investors expectations about stock performance or product development does not automatically become a lie or deliberate misrepresentation. According to the legislation, plaintiffs need to prove that the chief executive officer of the company approved the forward-looking statement while knowing it to be false (Spiess and Tkac, 1997). Moreover, failure to include the particular factor that ultimately causes the projection to be in error does not preclude that statement from being protected by the safe harbour as long as the factors that are identified are relevant to the projection (Johnson et al., 2001: 301).4 Consequently, some analysts feared that the Act would foster over-optimistic forecasts and projections, or, worse, a culture of lying. But Johnson et al. (2001: 298) claim that there is no evidence that forecasts issued after the Acts passage are more optimistically biased than those issued previously. The extent to which these risk factor statements circulate publicly and affect individuals decision-making and judgements about the expectations of firms in which they might invest their capital is somewhat unclear. The readership of these texts may extend from the staff at the SEC, to professional investment managers responsible for recommending or investing stock on behalf of trust or pension funds, to ordinary investors wanting to buy a stake in a listed company but aware of the need for due diligence. In practice,

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however, it is not clear that such publics actually read such statements despite the exhortations of investor websites such as Investopedia (cf. Fortun, 2008).5 How should a social scientist interested in the dynamics of science, capital and futures understand the production of these risk factor statements? The Private Securities Litigation Act and its establishment of the forward-looking statement is a key site of anticipatory practice in the legal underpinning of biocapital. Consequently, I suggest that we should think about these texts less in terms of accountability and more in terms of how, following Adams et al. (2009), they form part of an anticipatory regime in which story stock companies, such as those described by Sunder Rajan (2006) and Fortun (2008), are forced to tack back and forth between pessimistic and optimistic forecasts of equally conditional futures. To see these statements as otherwise serving to hold firms to account for their claims about the future would be to invoke the realist mode of testing expectations against underlying fundamentals. This is the view taken by the SEC and other actors in this arena when they speak about these texts as disclosures of risk factors. However, such texts are no more and no less speculative than the optimistic forward-looking statements of press releases . Theres no reason to allow oneself to be taken in by speculative genomic pessimism than by its cheerier sibling (Fortun, 2008: 201).6 It appears that the drafters of the legislation did not intend to enforce pessimism in order to hold firms accountable for the ebullient futures they project to attract investment and boost their stock value. Instead, pessimism was positioned to enable promises: companies could assert their promissory futures only by promising to be pessimistic. Unlike futures that are articulated in other sites of anticipation, such as the press release, pessimistic futures imagined in companies SEC filings are not performative: the firms do not enact these futures; instead, through the safe harbour provisions of the Act, they anticipate alternative futures they wish to avoid. Beyond serving their regulatory function, what kind of value do these statements have for the STS analyst, and what uses can analysts make of them? These statements delineate futures that are hoped to be unrealized, futures that are contingent and uncertain, and are precisely not envisioned as performative. Social scientists generally have not been interested in these kinds of futures. Mike Fortun, however, gives a striking example of how a social scientist can use such risk factor statements. He discusses how he drew on such statements to help inform public debate, as they provided counter-narratives to the largely ebullient and celebratory coverage of deCODE Genetics in the Icelandic press. Fortun recounts that at a public meeting in Reykjavik in 2000, he displayed on an overhead projector the sub-headings from the risk factors section of deCODE Genetics S-1 documentation, which was issued when it went public. In that section, deCODEs lawyers detailed all the things that could go wrong with the firm. This is a noteworthy and probably exceptional public use of such risk narratives to hold a firm accountable for its promises. Moreover, Fortun also suggests that these statements stake out a far more complex and dense social, scientific, political, legal and ethical terrain of genomics (Fortun, 2008: 201). On closer inspection, while boilerplating is clearly important to how this institutionalized pessimism is enacted within a mode of regulatory compliance, I suggest that these texts provide some interesting and perhaps unexpected commentary on the

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dynamics of risk and innovation in the context of contemporary biocapital. To follow through on this point, the next section provides a reading of the risk factor statements of three notable and controversial companies in the genomics and pharmaceutical sectors and explores the value of such pessimistic statements for a social science analysis.

These statements are just expectations: Reading the forwardlooking statements

The filings we shall examine were made by deCODE Genetics, DNAPrint Genomics Inc and NitroMed Inc.7 I chose these companies because they exemplify the volatility and the promise of commercialization in the life sciences, and I also have examined their particular activities in biobanking, personal genomics and race-based medicine in previous work (Tutton, 2007; Tutton et al., 2008). It should be noted that in each of these companies, investors and employees lost money and livelihoods when the value of stock in each of these companies collapsed, resulting in lay-offs as the firms were either bought out or restructured. The disclosures of these three companies articulate a series of interconnected uncertainties, which include: the validity or otherwise of their scientific ideas and assumptions; their ability to develop products and the likelihood of those products making a profit; the effect of changes in government regulation on their ability to sell and profit from their products; the force of public opinion on legislation and regulations that may disadvantage the companies or force them to change the way that they operate; and their ability to establish markets for their products. In what follows, I discuss how each of the three companies deal with such risks. The filings made by DNA Print Genomics stand out because of the different style in which they are written.

DeCODE Genetics Inc.

I suspect that deCODE Genetics Inc. hardly needs any introduction. Founded in 1996 and registered in the state of Delaware, this firm was created to sell the genetic, medical and genealogical information on the entire population of Iceland as sources of future medicines (McKie, 1997: 14). The plan developed by deCODE Genetics with the support of the Icelandic Parliament was to establish a Health Sector Database: an electronic patient record system that would be combined with a genealogical database (which was already in the public domain) and a new DNA database. deCODE Genetics became controversial, both for the way that it proceeded with an opt-out rather than an opt-in agreement with subjects in the Health Sector Database (which led ultimately to the Iceland Supreme Courts decision to strike it down as unlawful) and for how the sale of its shares was handled during the dotcom bubble in 2000. In common with other high-risk ventures listed on the NASDAQ, its share value fell sharply as the market collapsed. Despite having never actually constructed the Health Sector Database, deCODE did establish a large biobank of more than 140,000 samples and in 2007 branched out into the nascent personal genomics market with a product called deCODE Me. In 2009, after months of speculation about its financial health, deCODE filed for bankruptcy and, following restructuring, was re-launched as a private company in Iceland, owned by a number of investment organizations.

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To begin with, deCODE acknowledges the uncertain and contested nature of the basic science that underpins the research and development in which it has been engaged. In a 2008 filing, it asserted:
The products we hope to develop are based on the assumption that information about genes may help scientists to better understand complex disease processes. Scientists generally have a limited understanding of the role of genes in diseases, and few products based on gene discoveries have been developed . If our assumption about the role of genes in the disease process is wrong, our gene discovery programs may not result in products. (deCODE Genetics Inc., 2008)

Another significant risk is that the products or future products that deCODE and the other companies developed might not actually work, or wont be approved, might not compete with those of their rivals, or might not sell in sufficient quantities to justify the research that went into developing them. On its corporate website in 2009, deCODE Genetics described itself as developing drugs and DNA-based tests to improve the treatment, diagnosis and prevention of common diseases deCODE is delivering on the promise of the new genetics. In an SEC filing a more contingent account was given about its genes to drugs pipeline: We expect that it will be years, if ever, before we will recognize significant revenue from the development of therapeutic or diagnostic products.8 This is all the more interesting since a number of commentaries that appeared in the wake of deCODEs 2009 filing for Chapter 11 bankruptcy made reference to how the otherwise very good science produced by deCodes researchers did not lend itself to commercialization.

NitroMed Inc.
NitroMed Inc., best known for its controversial drug BiDil, was a small pharmaceutical company established in Cambridge, MA, USA. In 1999, NitroMed acquired the intellectual property rights to BiDil, a drug that its original owners were recasting preferentially to benefit African-American patients with congestive heart failure. In 2000, NitroMed filed a patent application establishing its claim, which was then granted by the US Patent and Trademark Office (PTO) in 2003 (Kahn, 2004). In order to gain approval to market the drug, NitroMed sponsored a clinical trial called A-HeFT (the African American Heart Failure Trial) that was halted early in 2004 because of its clear efficacy in treating this disease in its trial population of (self-identified) African-Americans.9 The results were published in the New England Journal of Medicine, and the Food and Drug Administration (FDA) granted approval in June 2005. Despite successfully achieving this regulatory approval, the company was soon subjected to intense criticism on a number of fronts, such as the design and conduct of its clinical trial (Kahn, 2008) and the claim that it was exploiting entrenched health disparities amongst racial/ethnic groups in the US for its own commercial gain (Boche, 2004; Ellison et al., 2008). Within a few years of BiDil being approved, however, the company found that the size of the market for this drug was smaller than expected. Layoffs ensued, and the firm stopped actively marketing BiDil. In early 2009, the firm was bought out by Deerfield Management, a leading healthcare investor company in the US.

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As with deCODE Genetics, NitroMed also noted in its November 2004 filing about the science that underpinned its business that its application of nitric oxide technology had yet to be proven in humans. Since this filing provided the scientific basis of NitroMeds product pipeline, there was the danger that company would not successfully develop and market its products. The uncertainties and contingencies of drug development were given lengthy treatment in this filing. One passage set out the many problems that the company might face when seeking to bring a drug to market: difficulties with obtaining regulatory approval to start a clinical trial; the possibility of getting unfavourable results; trials being suspended because of risks to participants; and, finally, the potential abandonment of the entire process:
Adverse or inconclusive clinical trial results concerning any of our drug candidates could require us to conduct additional clinical trials, result in increased costs and significantly delay the filing for marketing approval for those drug candidates with the FDA or result in a filing for a narrower indication than was originally sought or result in a decision to discontinue development of those drug candidates. (NitroMed 2004)

Regulation is both a necessary and uncertain process for biotech companies, and engagement with regulatory agencies is at the forefront of company risk perceptions. NitroMeds experience with BiDil is particularly interesting for our purposes, since it was one of the most controversial episodes in that firms history. NitroMed stated that its entire business plan depended on securing FDA approval:
We are heavily dependent on obtaining regulatory approval for and successfully commercializing BiDil, our most advanced drug candidate . If we fail to achieve regulatory approval or market acceptance of BiDil, our near-term ability to generate product revenue, our reputation and our ability to raise additional capital will be materially impaired, and the value of an investment in our stock will decline. (NitroMed, 2004)

Weighing up the potential outcome of its application, the filing acknowledged that:
To our knowledge, the FDA has never approved a drug product for use in a particular ethnic population. The FDAs receptiveness to drugs that are approved and marketed on the basis of different ethnicity-based therapeutic outcomes is untested and may be adversely affected by contrary scientific or public health evidence or political or legal factors. For example, scientific evidence could emerge that suggests that there is no physiological basis to support pharmaceutical development of drugs based upon ethnicity. Moreover, others may express the view that ethnicity is only a sociological concept and, accordingly, there is not a valid basis for the commercialization of medicines based on ethnicity. These factors or others could prevent us from obtaining FDA approval of BiDil. (NitroMed, 2004)

The filing therefore presents the regulation as being shaped by diverse actors within and beyond science. NitroMeds account of the then uncertain future of its application highlights technical concerns: it suggests that scientific evidence could emerge that would refute the companys claim of a pathophysiological difference with respect to heart disease between African-Americans and other racial/ethnic groups, undermining

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the rationale for approving BiDil as a drug prescribed for African-Americans (recalling that the drug had already failed in the 1990s tests to live up to its promise for the entire population). Interestingly, at the time there also was (and there still remains) no evidence for this pathophysiological difference. When the statement alludes to political and legal factors, it also highlights that there are others who advance the view that ethnicity is only a sociological concept an oblique reference to the heated debate in academic journals and the popular press about BiDil (Anonymous, 2005; Caulfield and Harry, 2008). Furthermore, such concerns about market acceptance continue even after approval. NitroMed observed that:
Key participants in the U.S. pharmaceutical marketplace, such as physicians, payors and patients, may not accept a product intended to improve therapeutic results based on ethnicity. As a result, it may be more difficult for us to convince the medical community and third-party payors and patients to accept and use our products. Our business is substantially dependent on market acceptance of BiDil. (NitroMed, 2004)

Clearly, there are many layers to this notion of market acceptance. To achieve market acceptance means not only reaching out to individual consumers, but also to the actors that mediate transactions in the pharmaceutical market, such as doctors who have the power to prescribe and the healthcare insurers who authorize the expenditure on the prescription of drugs. Even when a company achieves regulatory approval, gaining market acceptance is a crucial condition for the profitability of the company.

DNA Print Genomics Inc.

DNA Print Genomics was founded in 1999 by Tony Frudakis, a research scientist at Corixa Corporation, a pharmaceutical firm in the US. Frudakis had been involved with Corixas predecessor, GAFF Biologic, a DNA testing laboratory that aimed to reduce the cost of genetic testing to the point of being within the reach of everyday consumers. DNA Print was listed on the Nasdaq, and over the next few years it also acquired other companies. Its main services were in forensic, pharmacogenetic and consumer ancestry testing. However, it gained both a national and international reputation due to its forensic application of ancestry testing. The companys apparent achievements in identifying suspects in a series of US criminal cases attracted media attention and was the subject of a number of news stories.10 Despite the apparent success of this application, which formed part of the companys revenue stream, in early 2009 DNA Print Genomics went bust after a deal with Nanobac Pharmaceuticals to acquire the company fell through.11 While the filings of deCODE and NitroMed smack of having been drafted by lawyers, the tone of the 2006 filing by DNA Print is much more informal. For example, it frequently provides more accessible explanations of technical terms, such as single nucleotide polymorphisms. This more informal style is very much in evidence in the following statement on whether its products, which already were on the market, would generate profit in the longer term. The company expressed uncertainty, giving the following blunt assessment of the situation it faced:

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We remain skeptical that the consumer market for our products, which is mainly supported by genealogy enthusiasts, will remain strong enough to justify significant expenditures to develop new products. It is possible that the application of genetic testing to genealogy is a passing fad and that public interest in genetic genealogy testing will substantially decrease. If public interest decreases, our revenues generated from our products sold to the consumer market will likely decrease. (DNAPrint, 2006)

Such expressed scepticism about its own future is quite striking, and is typical of the different style in which this filing is written compared to those of the other two companies. This is also an interesting assessment of the market, since evidence on the number of products sold suggested that the market for genetic ancestry or genealogical services was the most successful form of direct-to-consumer genetic testing at that time (Wolinksy, 2006). In the same filing, DNA Print Genomics also reflected on reactions to the 2005 approval of BiDil by the FDA. It notes that the controversy that had surrounded BiDil could have wider implications for public opinion on such matters as genetic testing:
Recently, articles have appeared accusing the FDA and NitroMed of racial discrimination and claiming that no drugs should be developed using genetic testing that might separate out individuals by race, color or creed without regard to the benefit which might be caused for the African American patient. According to such critics, the potential harm in the form of increased discrimination far outweighs the benefits. Several noteworthy genetic scientists have also voiced their opinions that our technology and technologies similar to those developed by NitroMed are discriminating and should not be developed or approved by the Federal, State or local governments. (DNAPrint, 2006)

This statement links commentaries on the technologies developed by DNA Print Genomics with the controversy that had surrounded NitroMed Pharmaceuticals and the approval and marketing of BiDil. As point of fact, in designing their clinical trials for BiDil, NitroMed did not use genetic testing to select patients and no such test existed for the clinical prescription of that drug. As I indicated above, one of the major sources of controversy was the way the A-HeFT trial relied on self-identified social categories of Black or African-American as proxies for a predicted pathophysiological differences between categories in the human population. In any case, despite the apparent misunderstanding, this statement nonetheless reveals how DNA Print perceived the relevance of controversies about the products of other companies. In this instance, DNA Print positioned itself as sharing a zone of risk with NitroMed; a zone in which their products were also subject to critique by scientists on the grounds of racial discrimination. The risk factor statements of SEC filings made by these three companies therefore inscribe a pessimistic future distinguished by uncertainty, anticipations of failure rather than success, and possible risks and hazards instead of promises and hopes. Far from being formulaic and bland, such narrations provide interesting contrasts to corporate press releases, websites and media interviews that should be of interest to social scientists.

Promising pessimism
This paper focused on the institutional framework of the Private Securities Litigation Act and its legal protection of the forward-looking statements through which futures

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are projected. I argued that the co-articulation of pessimistic and promising futures in such statements constitute an important site of anticipatory practice for contemporary biocapital. In the regime of biocapital, companies are compelled to inhabit zones of contingency about their futures and to engage in anticipatory work in both promising and pessimistic registers. Pessimistic representations of the future cannot be treated separately from promissory representations (and surely the SEC would advise that one should never read them separately). Undoubtedly, the production of such statements keeps lawyers in business and serves to inform investment decisions, allowing the SEC commissioners to feel that they are protecting investors. Whether or not they serve investors as better guides to the future than positive claims made in company press releases should be left to others to debate. In this paper, I have been more interested in considering their value for social scientists. Earlier, I suggested that the SEC registration document is an instance of how every promising future is predicated on another more pessimistic future to be avoided. How such documents inscribe subject positions, identities and interests, and align various actors in a negative view of future circumstances, should be of interest for understanding the contemporary terrain of genomics, with its social, political, legal and commercial entanglements. These documents are not simply produced through boilerplating: on closer inspection they provide specific and contingent commentaries and observations that reveal complexities in the commercial worlds of the life sciences. They outline uncertainties with developing products and bringing them to market, underline the importance and difficulties of forming alliances, illuminate the pervasive role of regulation, and reveal the dense networks of interests and actors involved in those worlds. The statements quoted earlier from both NitroMed and DNA Print Genomics also drew attention to how social, legal and ethical debate among academics and other actors formed part of the risky terrain in which those companies operated. This helps to explain why in 2006 and 2007 representatives of NitroMed and other advocates of the approval of BiDil took the unusual step of attending academic meetings at MIT on developments in race, science and medicine, in which leading critics such as Troy Duster and Jonathan Kahn were speakers.12 During the second of these meetings, in 2007, it became clear that some supporters of the drugs approval were concerned that the arguments advanced by liberal social scientists, such as those speaking at that meeting, were having an adverse effect on the willingness of Health Maintenance Organizations to reimburse for prescriptions of the drug. Whether or not this claim was well supported, it vividly illustrated how participants in debates about new developments in science, technology and medicine can themselves become risk factors, from the point of view of companies promoting these developments, with potential implications for regulatory approval, market acceptance and profitability. From an STS perspective there is more to be said about the value of being pessimistic, even in such an institutionalized form. Projections of bad things that can happen foreground complexities and contingencies that interest STS scholars and other social scientists. Therefore, attention should also be given to the construction of pessimistic futures, since so much already has been devoted to positive expectations, hopes and promises. The SEC documents provide excellent material for further research, as this paper has only sampled the filings of three companies, and there is a wealth of potentially fascinating filings available from the SECs online database. This study is only a starting point

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for considering how pessimism is articulated and serves to shape expectations. While I have no desire to align myself with conservative commentators such as John Derbyshire, perhaps there is something to commend pessimism for analysts interested in understanding the social, political, legal and commercial entanglements of promises and expectations in the contemporary life sciences. This could be rather promising. Acknowledgements
I would like to thank Joan Haran and Mike Fortun for taking the time to read and comment on an earlier version of this paper, as well as the three anonymous referees who have all helped with strengthening my arguments. Thanks also to Mike Lynch who provided incisive editorial input into the paper. I also benefited from presenting this work at various conferences and workshops and, for their comments on those occasions, I would like to thank Adam Hedgecoe, Ruth McNally and Aaron Panofsky. The support of the UK Economic and Social Research Council (ESRC) is gratefully acknowledged. This work forms part of the programme of the ESRC Genomics Network at Cesagen. Notes 1. 2. 3. 4. Press release by deCODE (2009). Press release by deCODE (2009). See the corporate website for Intelligize, Inc. Available at: http://www.intelligize.com/. Under the terms of the Act, firms are not under a legal obligation to revise these risks once they have identified and articulated them. However, it does seem that in practice many companies choose to update these statements to reflect the changed circumstances of their organizations. See for example Kuepper (n.d.). To be sure, there is an element of disclosure involved since the firms must provide financial information, publishing details of revenues, losses and profits made to date. These filings are publicly and freely available to be read and downloaded from the US SEC website and searchable under company name and filing type. The SEC website is: www.sec. gov. See deCODE Genetics Corporate Website. Available at: www.decode.com. NitroMed Pharmaceuticals Inc. Press Release, First heart failure study in African Americans shows 43 percent improvement in survival. BiDil demonstrates significant improvement in survival rates in African American heart failure patients. Available at: www.nitromed.com. See Newsome (2007). See GenomeWeb (2009). These events were organized by the Center for the Study of Diversity in Science, Technology, and Medicine at MIT (Cambridge, MA, USA), between 2006 and 2008. For details of these events see the Centers website at: http://web.mit.edu/csd/CSD/Homepage.html.

5. 6. 7.

8. 9.

10. 11. 12.

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Biographical note Richard Tutton is Senior Lecturer at the ESRC Centre for Economic and Social Aspects of Genomics (Cesagen) at Lancaster University, UK. His research interests lie at the intersection of STS and medical sociology and his work centres on the role of expectations in science and technology and debates about biopolitics and biosocial identities in relation to new genetic knowledge. He co-edited (with Oonagh Corrigan), Genetic Databases: Socio-ethical Issues in the Collection and Use of DNA (London and New York: Routledge, 2004).

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