S Xenakis
email: sxenakis@eliamep.gr

Pride and prejudice: Comparative corruption research and the British case

In recent years, comparative corruption analysis has been fuelled by the growth of international survey data on related perceptions. Taking issue with the typological vein of such analysis, this article questions both the treatment of perceptions indices and the validity and pertinence of variables used to explain them. It is argued that perceptions are conflated with practice, whilst explanatory variables appear ungrounded in empirical reality. These limitations serve to reinforce expectations that corruption is a menace to be associated primarily with societies of the global periphery. Drawing on the supposedly paradigmatic case of Britain, the article suggests that the problem of bias in comparative scholarship is compounded by three factors: the failure of comparative and domestic-focused literatures to engage with one another in sufficient depth; the relative lack of qualitative research into corruption within core Western states; and the neglect of power in the study of perceptions and practices at comparative and domestic-focused levels of analysis.

Introduction

Over the past twenty years, corruption has been the subject of heightened attention nationally as well as internationally. It has been a key issue in efforts to promote good governance and rationalise aid policies, and has retained its topicality amidst recent moves to 'proof' domestic and international institutions from political and economic destabilisation associated with terrorism, transnational organised crime, and the global financial crisis [START_REF]Offshore banking, corruption, and the War on Terrorism[END_REF][START_REF] Holmes | Some concluding observations: A quadrumvirate in future?[END_REF]119]. Concurrently, the development of international survey data on perceptions of corruption-such as those gathered by the non-governmental organisation Transparency International (TI)-has rejuvenated a particular course of typological comparative research that seeks to explain why some societies rather than others have stable democracies, stronger performing economies, and less corruption. 1 Indeed, given the paucity of comparable data on corruption per se, the very growth of perceptions-based datasets has made them a seductive-if ultimately illusory-means of tracing the social, political, and economic determinants of corruption.

Yet perceptions surveys such as the 'Corruption Perceptions Index' (CPI) of TI have been accused of innate bias, due not only to their elite pool of respondents, but also the narrow experiences of bribery (in the main, bribery for routine official services, known as 'petty corruption') that they predominantly reflect (see further [START_REF] Andersson | The politics of perception: Use and abuse of Transparency International's approach to measuring corruption[END_REF][START_REF] Galtung | Measuring the immeasurable: Boundaries and functions of corruption indices[END_REF][START_REF] Ivanov | The limits of a global campaign against corruption[END_REF]). Concerns have thereby been focused more upon the crippling effects of corruption as perpetrated by state officials and political representatives in emerging and developing economies, than on the impact and forms of corruption stimulated by international business interests and underpinned by the political support of core Western states. Despite their powerful negative ramifications globally, the unfair trade and taxation regimes of the international financial system, and the fraudulent taxation and accounting practices of the advanced economies, have typically been treated either as legal and thus not corrupt behaviours, or else as white-collar, business-to-business fraud. Since the involvement of public officials or political representatives has not been regarded as sufficiently direct or overt, however, the latter have often been considered distinct from and unrelated to corruption (see further [START_REF] Holmes | Rotten states? Corruption, post-communism, and neoliberalism[END_REF]).

The severity of the political and economic upheavals wrought by the stream of major international scandals in recent years, involving intertwined business and political elites of the economically advanced world (including those such as Enron, BAe Systems, British American Tobacco, Fannie Mae, and Halliburton, amongst many others), has begun to stimulate academic debate about the need for a rethink of the assumptions underpinning much research in this area (e.g. [START_REF] Holmes | Some concluding observations: A quadrumvirate in future?[END_REF][START_REF] Holmes | Rotten states? Corruption, post-communism, and neoliberalism[END_REF][START_REF] Kaufmann | Legal Corruption[END_REF]). Amongst the academic community of typological comparative corruption researchers, however, there have been some indications of discomfort but few signs of urgency in addressing the disjuncture between contemporary realities and academic analysis (see e.g. [136]). Instead, typological comparative corruption research based on perceptions surveys has continued to generate findings that are at once selfflattering for the Western observer and condemnatory of others [START_REF] Bracking | Political development and corruption: Why 'right here, right now![END_REF][START_REF] Anders | Corruption and the secret of law: An introduction[END_REF]127]. Despite widespread acknowledgement of the dangers in equating perceptions with practice (e.g. [START_REF] Miller | Perceptions, experience and lies: What measures corruption and what do corruption measures measure?[END_REF]125,[START_REF] Kavanagh | Political culture in Great Britain: The decline of the civic culture[END_REF]), a significant vein of typological comparative corruption literature has persisted in surreptitiously conflating the two by attributing perceptions to variables (such as national economic structure, regime type, or religion) which are 1 See further [START_REF] Andersson | The politics of perception: Use and abuse of Transparency International's approach to measuring corruption[END_REF] on the impact of TI surveys upon both comparative academic research and anti-corruption initiatives internationally (compare [START_REF] Lancaster | Toward a methodology for the comparative study of political corruption[END_REF]). The use of typologies based upon given characteristics of societies is a technique that situates such comparative analysis within an influential interdisciplinary tradition of research stretching back throughout the twentieth century and beyond, into the relationship between culture, development, and good government. Critical accounts of this rich tradition can be found in [START_REF] Connell | Southern theory[END_REF], and Riesman's 1961 preface to The Lonely Crowd [116], for example. The imperative of looking further than the superficial traits of social, political, and economic systems in order to meaningfully explain practices such as corruption (see, e.g., discussion in [125,[START_REF] Geertz | The interpretation of cultures: Selected essays by Clifford Geertz[END_REF]), has often been overlooked by such literature for the convenience of treating the former as proxies for behavioural and inter-personal traits which cause the latter (see, e.g., [START_REF] Porta | The quality of government[END_REF]). destined to confirm their validity. That is to say, the way in which the correlation between selected variables and perceptions is explained implies that perceptions are sufficiently accurate guides to practice (even though this is known not to be the case; see e.g., discussion in [START_REF] Andersson | The politics of perception: Use and abuse of Transparency International's approach to measuring corruption[END_REF]). Furthermore, the very variables selected indicate underlying assumptions about their impact upon societies, but these are assumptions which appear to have little grounding in empirical reality.

Taking a closer look at the supposedly paradigmatic case of Britain serves to highlight the stark inadequacy of variables used in typological comparative analysis when compared to actual domestic social, political, and economic trends. 2 At the same time, the case of Britain also reveals a disjuncture between those variables employed by quantitative comparative literature and those by qualitative nationallyfocused studies. 3 In juxtaposing the two literatures, it is evident that the latter may be as compromised by bias as the former. Drawing on a broad, non-legalistic definition of 'corruption' as 'the use of public office or policy for private gain' (see further [START_REF] Holmes | Some concluding observations: A quadrumvirate in future?[END_REF][START_REF] Kaufmann | Legal Corruption[END_REF]), this paper makes three claims. Firstly, the validity of both international comparative and nationally-focused analyses would be enhanced if there were greater reflective engagement between them. Secondly, in order to help reduce bias and further greater comparability, the balance of nationally-focused corruption research needs to be redressed and the relative neglect of core Western states ended. Thirdly, consideration of domestic and international relations of power, which themselves shape perceptions and practices of corruption, need to be systematically incorporated into research at both levels of analysis in order to produce research that is both convincing and pertinent to contemporary experience. The article begins by setting out a range of variables commonly employed in typological corruption research to explain different levels of perceived corruption internationally, providing an overview of the logic by which variables have been correlated with corruption. Variables from this comparative literature are then applied to British realities, highlighting their deficiencies. Rather than proving the rule, the inconsistencies illustrated by the British case suggest the broader inadequacy of the nexus between perceptions and variables used by typological comparative research. The article goes on to summarise the hypotheses and assessments of UK-focused literature, as well as its limitations. The conclusion calls for greater efforts to ensure reflexivity between local, comparative, and international levels of analysis in order to diminish bias and increase the value of research.

Comparative corruption research and its prejudices

Recent years have seen a resurgence in the use of typologies that correlate levels of corruption with forms of social, political, and economic organisation, such as that proposed by Heidenheimer in the 1970s. Heidenheimer [START_REF] Heidenheimer | Perspectives on the perception of corruption[END_REF] argued that 'civic-culture'-based systems were representative of 'clean' medium-sized towns in America and Britain. 'Modern boss-follower' systems signified the gangsterism typified by the America of the early 20th century. 'Traditional patron-client' systems, meanwhile, denoted those less developed, more corruption-prone (but-as he suggested-'less corruption-sensitive') 'familist' societies, in which family interests are prioritised over those of the broader group or community (following [START_REF] Banfield | The moral basis of a backward society[END_REF]). During the 1990s, in the face of growing concerns in the US about the potential cost of weakened family ties for both civic culture and the furtherance of democratic norms, the argument was renewed. Fukuyama [START_REF] Fukuyama | Trust: The social virtues and the creation of prosperity[END_REF], in his 1995 work Trust: The Social Virtues and the Creation of Prosperity, asserted that the growth of firms is stymied in cultures where the family operates as a strong unit, since trust is limited to the family and does not extend sufficiently to sustain successful economic development. Fukuyama [START_REF] Fukuyama | Social capital and development: The coming agenda[END_REF] subsequently highlighted a relationship between familism and fraudulent entrepreneurialism, claiming, for example, that '[k]eeping one set of books for the family and another for the tax collector or outside investors is a prevalent practice in low-trust societies'. Comparative research has indeed found greater societal trust in strangers (e.g. as measured by the World Values Survey) to be positively correlated with enhanced economic performance [START_REF] Porta | Trust in large organizations[END_REF]. Hence the conclusion, as surmise, that 'familism is amoral, gives rise to corruption, and fosters deviance from norms of universalism and merit.' 4In far more neutral terminology, Lambsdorff [START_REF] Lambsdorff | Causes and consequences of corruption: What do we know from a crosssection of countries[END_REF], architect of the TI CPI, crystallised nine intermeshing themes of cross-national analyses of corruption: the size of a state's public sector, the quality of their regulation of public financial affairs, the degree of domestic market competition, the structure of government, the degree of governmental decentralisation, the impact of national 'culture', values and gender balance in official positions, and the role of 'invariant' features such as geography and history. Hofstede [START_REF] Hofstede | Culture's consequences: International differences in work-related values[END_REF], meanwhile, proposed five dimensions of 'culture' to help explain, and predict, behaviour by different societies: power distance, individualism (versus collectivism), masculinity (versus femininity), uncertainty avoidance, and the less-commonly cited long-term (versus short-term) societal orientation. Extrapolating from Hofstede's typologies, some theorists of corruption have utilised the hypothesis that greater political 'power divides' indicate authoritarian rule, with submissive subordinates and overblown bureaucracies that extort from citizens, while more egalitarian divides signify harmonious pluralism and low tolerance for, and practice of, corruption. 'Collectivist societies' (e.g., Mexico, Indonesia, India, Poland, and the Philippines) are associated with the primacy of group loyalty over efficiency, and higher potential for prevalent corruption. 'Individualistic societies' (e.g., Denmark, Finland, and New Zealand) control their citizens' behaviour more through internal pressure (guilt), encourage self-reliance and performance-based rewards, and thus reduce the potential of corruption (see further [START_REF] Davis | Perceptions of country corruption: Antecedents and outcomes[END_REF][START_REF] Husted | Wealth, culture, and corruption[END_REF]).

According to the masculinity/femininity thesis, countries with a highly masculine (competitive) culture (e.g., Austria, Japan and Venezuela) are likely to have greater levels of national corruption than a society with a predominantly feminine (compassionate) culture, such as that of Finland or Sweden [START_REF] Davis | Perceptions of country corruption: Antecedents and outcomes[END_REF][START_REF] Husted | Wealth, culture, and corruption[END_REF]. Equally, societies valuing 'uncertainty avoidance' (e.g., Greece, France, and Korea) tend towards higher levels of corruption (corruption being used to secure certain outcomes) and can be identified by their desire for rules, regulations, and strong nationalism. In contrast, countries with lower levels of uncertainty avoidance (e.g., Britain, Denmark, and Sweden), are characterised as enjoying 'lower levels of [societal] anxiety and job stress, and less emotional resistance to change', their flexibility leading to less corruption (see further [START_REF] Davis | Perceptions of country corruption: Antecedents and outcomes[END_REF]). Overall, Husted concludes, 'we can tentatively describe a cultural profile of a corrupt country as one in which there is high uncertainty avoidance, high masculinity, and high power distance. In the case of collectivist and high power distance countries, high masculinity is the single cultural variable that contributes to corruption' [68:354].

A bolder tripartite reformulation has proposed that collectivist cultures 'spawn' segregated societies, are characterised by paternalism-authoritarianism and low social trust, and contain 'virtually no sustained elite or mass opinion' to condemn behaviour commonly viewed as corrupt by Western standards [25:12]. Individualistic cultures are presented as 'more integrated and complex', view government as 'strictly utilitarian' (to serve citizens), but can have the disadvantage of approaching politics as a business, which leads in turn to strong patron-client relations between political parties and other interest groups, and a minimal level of societal trust. Government bureaucracies are overblown, and corruption can become systemic 'within many, if not all, of the state's political, economic and cultural institutions' [START_REF] Collier | Explaining corruption: An institutional choice approach[END_REF]. Finally, egalitarian cultures are politically pluralist, are characterised by 'cosmopolitan social trust', and demonstrate strong elite and popular adversity to corrupt behaviour. Corruption is only incidental to regular political behaviour in such cultures (since it is impossible to eradicate entirely), but the rule of law is strongly upheld. Moreover, free 'market material resource systems' correspond to egalitarian societies, for they 'enjoy the maximum openness and state resource management is highly transparent', thereby presenting the fewest opportunities for corruption ([25:21]; see further discussion in [START_REF] Ivanov | The limits of a global campaign against corruption[END_REF]122]). Collier suggests that the most corrupt types of cultures can be found in 'the developing states of Eastern Europe, the Mediterranean littoral, Latin America, Asia, Africa, and the Pacific' [25:8,12]. If initially concerning, individualistic societies are identified in 'non-Puritan sections of England, Wales, the United States, Australia, New Zealand; Ireland; Central Europe; and French-Speaking Canada'. But reassurance is at hand, as the egalitarian model is also detected in 'Puritan sections of England, the United States, Australia, and New Zealand; Scotland, Northern Ireland, Scandinavia, North Sea states, Jewish states; and English-speaking Canada'. This model unsurprisingly applies to a select few, for '[t]he Heritage Foundation rates only 10 world states as having true market systems' [25:21]-evidently the preserve of the genuinely egalitarian society, according to such a perspective.

Moving closer to the British target of this article, it is important to underline that strand of literature which focuses more specifically upon the role of democratic and religious traditions in its explanation of comparative international experiences of corruption. Despite rising concerns in recent years about corruption within wellestablished Western democracies (see, e.g., [START_REF] Bracking | Political development and corruption: Why 'right here, right now![END_REF][START_REF] Della Porta | Introduction: Democracy and corruption[END_REF][START_REF] Heywood | Political corruption: Problems and perspectives[END_REF], 101]), the consensus amongst corruption experts remains that democratic states-especially those with longer experiences of democratic rule-are least corrupt, particularly in comparison with authoritarian states [124]. The Index of Democracy compiled by Freedom House, for example, has been cited-albeit tentatively-in support of the hypothesis that there is a negative correlation between democracy and corruption, since democracy correlates inversely with the TI CPI of 1998 [87:123]. 5A variety of democratic practices are believed to limit the potential for corruption, from the ability to remove by vote the government, to the role of the opposition and a free press in exposing corruption of governments (ibid.). In particular, 'plurality' parliamentary democracies (single-winner voting systems) have been considered to be more negatively correlated with corruption than those with proportional representation systems (especially if combined with presidential forms of government; [START_REF] Kunicová | Electoral rules and constitutional structures as constraints on corruption[END_REF]). This is despite the fact that plurality systems appear to secure less electoral accountability than those which combine majoritarian and proportional elements (i.e. presidential or semi-presidential systems of government) [START_REF] Hellwig | Electoral accountability and the variety of democratic regimes[END_REF]. A key study that has furthered the use of parliamentary democracy as a favoured indicator of low levels of corruption has been that of Treisman, who found having a system of common law inherited from former British rule to be significantly positively associated with lower levels of national corruption. 6 Drawing on La Porta et al. [START_REF] Porta | The quality of government[END_REF], Treisman [133] explains that common law systems-found mostly in Britain and former British colonies-are associated with superior government (i.e., contra the view that the inbuilt inadequacies of such systems hinder prosecution of corruption [101,115]). Common law traditions are described as having been formed in opposition to state power, generating greater protection of individual property rights. In contrast, civil law traditions, generated by the state, are treated as representative of essentially top-down, authoritarian governance (see e.g. [START_REF] Porta | The quality of government[END_REF]).

A further, equally important negative correlate of corruption suggested by typological comparative corruption research is one that is also closely identified with the British case: Protestantism [START_REF] Gerring | Political institutions and corruption: The role of unitarism and parliamentarism[END_REF][START_REF] Lipset | Corruption, culture, and markets[END_REF]122,133]. A range of explanations is available as to why this is so. The Protestant ethos, it is suggested, is more conducive to norm-adhering behaviour, imposing far more responsibility on the individual for their sins and demanding greater righteous living from congregations than that expected by Catholic, Anglican, and Orthodox Churches [START_REF] Lipset | Corruption, culture, and markets[END_REF]. Alternatively, it is because Protestantism is more tolerant of challenges to authority and of individual dissent, 'even when threatening to social hierarchies', which 'renders Protestant societies more likely to discover and punish abuses' [133:527]. These arguments draw extensively from La Porta et al., who consider the correlation between religion and quality of government. They propose that countries whose populations belong primarily to 'hierarchical religions'-e.g., Catholic, Islamic, and Greek Orthodox-'exhibit inferior government perfor-mance' to that of largely Protestant countries. 7 It is suggested that hierarchical religions are more interventionist in the individual lives of their congregations, and that they became established religions by supporting state power. Societies with hierarchical religions have less efficient state bureaucracies (since 'they may have developed from religious ranks'), fewer civil rights ('state-supported intolerance'), and inferior provision of social goods ('religions that rely on the auditory absorption of information (such as Catholicism) discourage literacy') [81:233-4]. In other words, such religions have been interpreted as corresponding to the communitarian, authoritarian model of government whose constraints and normalisation of paternalism, cemented via hierarchical, fragmented networks of trust and obligation, stimulate higher levels of corruption. La Porta et al. base their approach in part on the argument of Putnam et al. [114] that 'hierarchical religion discourages horizontal ties between people' and thus retards the formation of trust that is extra-familial [82:333]; the form of trust necessary for the development of healthy free market economies (such as enjoyed by egalitarian societies, as outlined above). They also use the work of Landes [START_REF] Landes | The wealth and poverty of nations: Why some are so rich and some so poor[END_REF] to explain that the root failure of Catholic and Muslim countries to match the success of Protestants in economic development lies in their shift, in the 15th Century, towards intolerance, xenophobia, and closed-mindedness, which has contributed to a durable social hostility towards institutional development [81:224] and, by implication, to a higher propensity for corruption and weaker positions in the international economy.

A multitude of critiques exist for each facet of the arguments presented above, from their 'othering' (neo-)colonialism, to the sheer breadth of contradictory evidence (including, for example, the deleterious trends associated with advanced capitalism in Western societies), to their unsubstantiated extrapolations and apparently limitless potential for extension: why, indeed, stop at global latitude (e.g., [START_REF] Porta | The quality of government[END_REF]) as a correlate of corruption when one can use average daily temperature as well? 8 Space unfortunately prohibits full discussion here, and the following critique will be restricted by reference to the British case. In any case, the continued momentum of such typologies points to their broader and more seductive function. By identifying the stereotypical traits of societies with apparently higher levels of corruption, they direct blame towards the weak for their predicaments and may thereby help assuage latent guilt amongst Western observers for the unequal impact of international political and economic systems of governance. 9

The misfit between comparative variables and local realities

The deficiencies of a reductive approach to comparative corruption analysis become starker when juxtaposed with a supposedly paradigmatic case study. Britain constitutes just such a case; when included in international comparative studies of corruption, it is unfailingly treated as an example of a relatively un-corrupt country (see [START_REF] Adonis | The UK: Civic virtue put to the test[END_REF][START_REF]Corruption in contemporary politics[END_REF][START_REF] Della Porta | Introduction: Democracy and corruption[END_REF][START_REF] Harris | Political corruption: In and beyond the nation state[END_REF]). Britain is typically painted as the model state [START_REF] Leys | What is the problem about corruption?[END_REF] that managed so successfully to reform the mechanisms of its public life as to largely dispense with common practices of bribery, clientelism, and other misuses of public office subsumed within the category of 'corruption'. One may question whether its reputation is justly deserved, or even whether it is still intact. There have been media and NGO reports of a steady rise in negative domestic and international perceptions of corruption in Britain over recent years, seemingly confirmed by its slip from eleventh to seventeenth place in the TI CPIs of 2005 and 2009. 10 Notwithstanding the spasmodic avidity of the British media for news of scandals, and in contrast to other forms of crime that receive sustained attention and analysis from both the media and the state, however, corruption in Britain has not received a comparable level of critical attention from academia (see similar discussion in [START_REF] Kebschull | Political corruption: making it the "significant other" in political studies[END_REF]109]). Indeed, this has also remained the case despite the increasing salience of the issue for British and foreign companies concerned with establishing an 'equal playing field' for international business.

Whether or not the reputation of Britain as a model of low corruption still pertains, its long-standing role as an exemplar remains apposite to evaluating the use of social, political, and economic variables, in tandem with perceptions indices, in comparative theorisation of corruption. On the one hand, levels of perceived corruption in Britain have remained relatively low, but on the other, variables commonly employed to explain such perceptions do not fit with the British experience. This rupture between perceptions and the supposed correlates of low corruption underlines the weakness of such theorising more generally. The problematic nature of the British case underlines the point that there is no obvious or proved relationship between actual levels of corruption, perceived levels of corruption, and superficially-defined national social, political or economic characteristics.

To briefly recap and extrapolate from the typologies presented above, one would expect lower levels of corruption in the UK to be explained by its civic culture, the weakness of its family units, its predominant moral individualism (as opposed to amoral familism), its relaxed acceptance of risk-taking (low uncertainty avoidance), and its internalised rather than extrinsic web of normative proscriptions. Alongside which, its Protestantism has contributed to its healthy free-market economy (reinforcing moral compulsion by insisting upon the individual's responsibility for avoiding sinful corruption), high levels of xenophilic social trust, low power distance 10 As scored amongst 158 and 180 country rankings, respectively. TI Corruption Perceptions Index data is available at: http://www.transparency.org/policy_research/surveys_indices/cpi). Such shifts in country positions may be affected as much by changes in methodology, sources, and numbers of other country participants as much as by country performance per se (see [START_REF] Galtung | Measuring the immeasurable: Boundaries and functions of corruption indices[END_REF]). Nevertheless, the repercussions of the al-Yamamah affair were widely blamed for this slip ( [START_REF] Cockroft | Corporate corruption: Challenges in a changing world[END_REF]; 'OECD attacks UK failure on corruption', The Financial Times, 17 August 2008; 'Bribery team probing BAE case alleges dirty tricks', The Independent, 10 June 2007).

(i.e., high levels of civic engagement), and strong democratic and common law traditions (tolerance of dissent, anti-authoritarianism, strong but minimal rule of law that restricts the power of the state, and a vibrant political opposition and active free media that root out corruption), as well as a comparatively feminine (less competitive, more compassionate) culture.

To what extent, then, does the model of democratic and civic health featured in comparative corruption research correspond to British realities? The recorded postwar decline in respect for those in institutional positions of authority [112] has not reduced the 'power distance' between government and citizens (contra [117]). Rather, the era has been marked by the centralisation of political power and its increasing concentration amongst elites within political parties themselves (see e.g. [START_REF] Heffernan | Prime ministerial predominance? Core executive politics in the UK[END_REF]103]). From party conferences to election campaigning, the public engagements of leading politicians are carefully managed performances in which encounters with common citizens have been largely eschewed for the safety of handpicked audiences, whilst the oversight and negotiation fora of parliament and ministerial cabinets have also seen their roles sharply curtailed and often bypassed (see e.g. [START_REF] Heffernan | Prime ministerial predominance? Core executive politics in the UK[END_REF]121]; 'State-managed rings of confidence', The Guardian, 5 May 2005). Moreover, participation in national political elections has reached historically low levels in recent years. At the general election of 2001, electoral turnout was 59%, the lowest for any general election since universal suffrage in 1918, and the number who did not vote was greater than that which voted for the winning party [START_REF] Baston | Tuning out or turning off? An analysis of political engagement and what can be done about it[END_REF]. The 18% decline in voter turnout over the three successive general elections of 1992, 1997 and 2001, was greater than the largest declines found across similar consecutive elections in other established liberal democracies internationally [START_REF] Dunleavy | Developments in British politics 7[END_REF]. Turnout for the general elections of 2005 and 2010 were marginally better, at 61.4% and 65.4% respectively, but were still amongst the lowest recorded since the beginning of the 20th century ( [START_REF] Cracknel | General election 2010: Preliminary analysis[END_REF][START_REF]Election 2005. Turnout: How many, who and why?[END_REF]). Turnout in 2005 proved to be the lowest for a national parliament amongst the original fifteen states of the European Union, although it was consistent with low electoral turnout commonly recorded for other first-past-the-post systems, such as that of the US and Canada [START_REF]The UK General Election of 5 May 2005: Report and analysis[END_REF]. The 2005 general election also left the British government with one of the weakest electoral mandates of any democratic government internationally, with only 21.6% of electoral support [START_REF]The UK General Election of 5 May 2005: Report and analysis[END_REF].

With regard to other common indicators of political and civic engagement, Britain has also experienced one of the steepest reductions in membership of political parties amongst the older European democracies. Since 1980, political party membership has fallen by over 50% [START_REF] Mair | Party membership in twenty European democracies, 1980-2000[END_REF], and by 2008 only 4% of the population had donated money or paid membership to a political party in the previous two to three years [START_REF]Audit of political engagement, 5: The 2008 Report[END_REF]. 11 The proportion of the population that are members of civic organisations in general has appeared to remain fairly stable at 50% between 1981-1999, but memberships have increasingly been concentrated amongst higher socio-economic status groups, where multiple memberships are common, while membership amongst lower socio-economic groups has declined. Organisations that involve face-to-face interaction in working towards a common endeavour have had declining memberships, while those in which a private benefit is received at a distance (e.g., online internet groups) has increased, provoking debate on the suitability of voluntary membership as a reliable indicator of contemporary civic participation [START_REF] Grenier | Social capital in Britain: An update and critique of Hall's analysis[END_REF].

What of Protestantism? Although 72% of the British population in 2005 still professed to be Christians, there has been a significant long-term decline reported in specifically Christian beliefs over the twentieth century, as well as in regular church attendance. From 1979, when 12% of the population regularly attended church, the figure dropped to 6.4% by 2005 [START_REF] Grenier | Social capital in Britain: An update and critique of Hall's analysis[END_REF][START_REF] Davie | Europe: The exception that proves the rule[END_REF], whilst recent forecasts of the disestablishment and demise of the Church of England by the year 2020 have seemingly provoked little public concern [START_REF] Brierley | British religion in the 21st century: What the statistics indicate[END_REF]. Furthermore, whilst the two largest Christian churches in Britain (Anglican and Roman Catholic) have been in sharp decline, it is Neo-Pentecostalism-whose competitive evangelical values [START_REF] Martin | The evangelical upsurge and its political implications[END_REF] tend to be viewed as challenging those of traditional Christian Churches in Britain [START_REF] Bruce | Religious toleration and organisational typologies[END_REF][START_REF] Hunt | Deprivation and Western Pentecostalism revisited: Neo-Pentecostalism[END_REF][START_REF] Mcgrath | The twilight of atheism: The rise and fall of disbelief in the modern world[END_REF]-that has been the sole Protestant movement to see significant growth in attendances since 1989 [START_REF] Brierley | British religion in the 21st century: What the statistics indicate[END_REF][START_REF] Bruce | Christianity in Britain, R.I[END_REF]. 12 Whether or not Protestantism is seen as more conducive to anti-corruptive norm-adhering behaviour [START_REF] Lipset | Corruption, culture, and markets[END_REF], or to a deterring, corruption-exposing dissent [START_REF] Porta | The quality of government[END_REF]133], one may well wonder of what relevance it is as an explanans of democracy or levels of corruption today (see [START_REF] Bruce | Religious toleration and organisational typologies[END_REF]).

'Protestant ethics'-'personal discipline, hard work, frugality, and a respect for learning'-may have facilitated capitalist growth in its early phase, but such values are unlikely to have assisted continuing economic expansion, nor indeed remain prevalent in contemporary advanced capitalist societies [START_REF] Berger | The desecularization of the world: A global overview[END_REF]. Wealthy Protestant societies are said to have become less 'achievement-oriented' than Catholic or other traditionalist societies [87:120-1]. Unfortunately for non-Protestants, the tables have simply been turned, as lower levels of achievement motivation are now correlated with less corruption [see 8]. Even if Protestant traditions did create a uniquely nutritious cultural and political consensus in support of secularism that allowed liberal democracy to flourish in the West, surely their decline and transformation (at least in Europe) should be acknowledged and the accompanying implications addressed (see [67:140-41]; and [START_REF] Davie | Europe: The exception that proves the rule[END_REF]).

If patterns of political and civic participation are faltering in Britain, what of the relationship between its economy, extensive (non-familist) networks of social trust, and meritocratic principles? In 2004, the then Chancellor of the Exchequer of the Labour government, Gordon Brown, announced in his Budget statement to parliament that since 1997 the British economy had experienced sustained growth, with overall growth since 2000 almost twice that of Europe and higher even than that of the United States. Indeed, he claimed, 'Britain is enjoying its longest period of sustained economic growth for more than 200 years […], the longest period of sustained growth since the beginning of the industrial revolution' [START_REF] Brown | Chancellor of the Exchequer's budget statement[END_REF]. Despite sustained economic growth, however, social (extra-familial) trust fell from 56% in 1959 to 31% in 1995, according to the British results of the European Values Survey in 1959 and subsequent World Values Surveys, a drop that appears to have stabilised since 1997 [START_REF] Healy | The well-being of Nations: The role of human and social capital[END_REF]. 13 Furthermore, wealth inequality in Britain rose by 20% between the mid-1980s and the early 1990s, the largest increase amongst all countries surveyed during that period, including the US [51:22]. Income inequality in the UK in 2008 was equal to its highest-ever level since records began in 1961 [START_REF] Brewer | Poverty and Inequality in the UK: 2008[END_REF]: as the wealthiest 1% of the population saw their share of total personal wealth increase from 17% in 1988 to 23% in 2002, the bottom 50% saw their share drop from 10% in 1986 to 6% in 2002 [36:4]. As relative poverty has increased, so has the share of wealth held by the wealthiest, although the proportion of households that are wealthy has itself fallen (op. cit., 84). 14 To the extent that intergenerational mobility can be regarded as a measure of economic opportunity, 'life chances', or 'meritocracy' accorded by a particular system, the recorded decline of social mobility in Britain over recent decadesreaching the lowest level amongst eight European and North American counterparts in 2005 (excepting the US)-suggests that the country can hardly be characterised as internally well-integrated or egalitarian (see [START_REF] Blunden | Intergenerational mobility in Europe and North America. Centre for Economic Performance[END_REF]; see further [START_REF] Ipsos | Survey of public attitudes towards conduct in public life[END_REF]; 'Riven by class and no social mobility, Britain in 2007', The Guardian, 20 October 2007; [104]). As has been repeatedly found by international studies [START_REF] Lijphart | Unequal participation: Democracy's unresolved dilemma[END_REF]107], wealth inequalities in Britain are correlated with levels of political and civic participation. Higher socioeconomic status groups not only profess a far greater interest in, and knowledge of politics than lower socio-economic status groups, but are also much more likely to both be on the electoral register and to vote in political elections, to contact a local councillor or Member of Parliament, and to be satisfied that the system of government works well [START_REF]Audit of political engagement, 5: The 2008 Report[END_REF][START_REF] Keaney | A citizen's duty: Voter inequality and the case for compulsory turnout[END_REF]. In particular, those with higher educational backgrounds-an attribute with an increasingly strong relation to the level of family income [START_REF] Blunden | Intergenerational mobility in Europe and North America. Centre for Economic Performance[END_REF]-broadsheet newspaper readers (and the young), have been found to hold greater confidence in national politicians and standards of public life in Britain, and tend to express far less cynical views about the comparative roles of merit and clientelism in the selection of appointments to public office [START_REF] Hayward | Survey of public attitudes towards standards in public life[END_REF][START_REF] Hayward | Survey of public attitudes towards standards in public life[END_REF]. The role of the media may be explained in part by the existence of powerful libel laws and inherent conservatism which have functioned to stifle coverage of corruption [101]. Nevertheless, high overall confidence in the standards of British public life has also been in slow decline [START_REF] Dunleavy | Voices of the people: Popular attitudes to democratic renewal in Britain[END_REF][START_REF] Hayward | Survey of public attitudes towards standards in public life[END_REF]. 15 13 Results from the British Social Attitudes Surveys mirror the fall in trust while, nevertheless, consistently finding higher levels of social trust. They, too, show a stabilisation of decline from 1997, however, at around 43 percent of respondents [START_REF] Grenier | Social capital in Britain: An update and critique of Hall's analysis[END_REF]. 14 Whilst relative poverty between the most and least affluent has increased, there has been a decline in relative poverty amongst those with middling incomes [START_REF] Hills | A more equal society? New labour, poverty, inequality and exclusion[END_REF]. From the late 1990s to 2004 there was a 2-3 percent decline in relative poverty, but rates then began to climb again [START_REF] Brewer | Poverty and inequality in the UK: 2007[END_REF]. 15 Successive surveys carried out between 2004-2008 by BMRB Social Research for the Parliamentary Committee on Standards in Public Life have charted a slow decline in levels of public trust in parliamentarians and government ministers (although the latter are trusted less). The vast majority of respondents remain confident that MPs and ministers do not take bribes, but far fewer are confident that they do not use power for their own gain [START_REF] Hayward | Survey of public attitudes towards standards in public life[END_REF]. According to the TI Corruption Barometer of citizens' perceptions [132], British respondents were amongst the most pessimistic about the prognosis for corruption in their country; 72 percent of British respondents expected corruption to increase in the coming years, and 64 percent believed their government to be ineffective in combating corruption.

The specific implication of lower and increasingly unequal levels of participation in civic and political life is the expansion of an already-recorded entrenched bias in the political system towards the interests of the wealthier at the expense of the poorer sections of the population [START_REF] Lijphart | Unequal participation: Democracy's unresolved dilemma[END_REF]107]. 16 As demonstrated by international comparative research, income inequality is far more prevalent where voter turnout is low (i.e., concentrated more amongst wealthier voters), contrasting with a general tendency towards expansion of government spending, redistributive and welfare policies, and declining inequality in tandem with higher levels of voter participation [START_REF] Mueller | The economic effects of democratic participation[END_REF].

In sum, variables often employed by international comparative studies of corruption appear to be misleading, inappropriate, and more generally incommensurate with the reality of British political and social life (see [START_REF] Kavanagh | Political culture in Great Britain: The decline of the civic culture[END_REF] for a parallel critique on civic culture literature). Equally evident from the following brief overview of domestic research into British corruption, however, is that those studies which focus exclusively on the local, without systematically considering both the relational impact of international structures of power and the comparability of contemporary practices in different local contexts, are no less likely to produce a biased account of corruption.

Localised corruption research and its limitations

Nationally-focused studies of the UK tend to emphasise the roles of structural path dependency and current normative and institutional standards, in addition to national affluence, to account for the apparent health of British public life. Low levels of corruption today are commonly treated as the product of strong and sound institutional frameworks established by the 18th and 19th century reforms of Parliament and the civil service, which account for the continuity and expansion of practice across generations [e.g., [START_REF] Adonis | The UK: Civic virtue put to the test[END_REF][START_REF] Doig | Political corruption in the United Kingdom[END_REF][START_REF] Harris | Political corruption: In and beyond the nation state[END_REF]. Furthermore, rather than the development of a refined ethical consensus, pragmatic recognition of the diverse social, economic, and political pressures which demanded institutional answer, more commonly appears as the impetus behind British anti-corruption reforms over time; highly significant economic and political crises accompanied each step of major meritocratic reforms of parliamentary democracy and the civil service. In the 19th century, for example, the British aristocracy, fearing that its reputation for corruption would leave it vulnerable to the sort of revolutionary upheavals being experienced by France, was prepared to open the doors of political power to the bourgeoisie that were clamouring for entry and demanding greater political recognition of their economic power [START_REF] Adonis | The UK: Civic virtue put to the test[END_REF][START_REF] Harris | Political corruption: In and beyond the nation state[END_REF].

Concerning the role of anti-corruption norms within British society, there is considerable divergence of opinion regarding which elite values have been responsible for the reduction of corruption, and which for its continual reproduction. Whilst some have portrayed the liberal bourgeoisie and their political representatives as a vital historic force for the furtherance of meritocracy, moral conduct, and modern democratic opposition [e.g. 1], for others, the entry of the liberal bourgeoisie into the political elite almost seems to have been the beginning of the rot [e.g., 52]. The early 1920s, for example, saw the infamous profligacy of, and under, the notable social reformer, Liberal Prime Minister Lloyd George, state honours being sold at excessive rates in return for party funding, not to mention his own ostentatious rapacity that made him the 'first prime minister since Walpole to leave office flagrantly richer than he entered it' ([129], cited by [100]; see also [START_REF] Doig | Corruption and misconduct in contemporary British politics[END_REF]; [123]). Such histories give cause to question the notion of a golden era of British anti-corruption efforts and, in particular, the time-span of any path-dependent ethical consensus in British public life.

The disagreement between traditional conservatives and liberal reformers, in which they accuse each other of having brought about more political corruption whilst regarding their own side as a bastion against corruption, is of enduring relevance. For traditional conservatives, respect for, and adherence to, old aristocratic norms of gentlemanly behaviour (cultivated primarily by class and only later acceptably by elite institutions of higher education), a paternalistic sense of duty to the state qua the public (the duty to rule well), as well as care for those of lower socio-economic status, have been the primary generator of clean government in Britain. 17 By contrast, political corruption has been fuelled by the rise of a ruthlessly amoral and avaricious ('masculine') elite, driven by an individualistic, free-market credo, who have no respect for the 'public ethos' (see further [START_REF] Holmes | Rotten states? Corruption, post-communism, and neoliberalism[END_REF]100]). Whether their emergence is today associated more with the premiership of Margaret Thatcher [START_REF] Doig | Untangling the threads[END_REF] or of Tony Blair and the 'debauched' generation of the 1960s and '70s [103], the new elite are portrayed as arrogantly believing themselves even more justly ordained to rule than their forebears in light of their superior intellectual and moral merit as individuals, and certain of their entitlement to all the rewards that public office can help to secure.

It may at this point be helpful to recall that gentlemanliness has been one of the most oft-cited attributes of so-titled 'honourable members' of parliament in explanations of persistently high standards in public life. Adamant reaffirmations of the good, public-spirited intentions of the overwhelming majority of members of the Houses of Parliament are fairly ubiquitous once a case of 'bad apples' has been discovered. At the same time, the strength of the idea that those in senior public roles could and should be relied upon to police their own behaviour-the 'club ethic' of the elite-has also been deemed responsible in some measure for the failure of the UK to develop a written constitution or formal legal rules and working practices delineating their rights and duties [135]. Although today threatened by the demand for further transparency reforms, the language of gentlemanly conduct has played an essential role in defending parliamentarians' rights to self-oversight in the 17 Thus, in terms that ironically echoed and confirmed the worst fears of Queen Victoria-that appointing people to high public office on the basis of their ability-might let in 'low people without breeding or feelings of gentlemen' (quoted in [START_REF] Cohen | The growth of the British civil service, 1780-1939[END_REF]; cited in [START_REF] Kellner | The civil servants: An inquiry into Britain's ruling class[END_REF]), writes Neild [100:205-6], 'two old British elitesthe patrician politicians and the administrative class of the civil service [..] helped to produce 'clean government' in Britain [..]. They shared an Oxbridge educational background; they shared, or at least respected, a notion of public service. And they shared power […]. Those ministers that did not come from Oxbridge had usually come up through the professions or trade unions; they had a more austere notion of what conduct was acceptable than the politicians of today.' Over the course of the twentieth century, however, the dominance of the civil service by Oxbridge graduates itself came to be seen as unconscionably elitist (see further [111]). face of successive corruption scandals over time. The management of the two Houses of Parliament, for example, from the maintenance of Chatham House rules to ethical standards of conduct, has been strongly based upon mutual trust and voluntarism amongst members [106]. But such trust is rooted in the very sorts of ('collectivist') local networks, personal loyalties, friendships, and clientelist relations that are commonly regarded by outsiders as corrupt or corruption-prone [110]. For some theorists, such as Philp, there thus exists a dilemma: more democracy, less trust, and more corruption, or less democracy, more trust, and less corruption? In other words, the cost of more transparent government is greater public scrutiny of those in public office, which undermines the mutual trust of the elites and eats away at customary patterns of good conduct that such trust generates, thereby increasing the likelihood of corruption. Alternatively, less transparency and regulation allows relationships of mutual trust amongst the elites to flourish, and this maintains a naturally low limit on levels of corruption.

For those following in the footsteps of generations of liberal reformers, the paradoxical demands of ensuring trust both amongst the elite and between the elite and the public, have been significantly tempered by elite commitment to enlightened meritocracy, the disbandment of illegitimate aristocratic privileges (wherever deemed possible), and the promulgation of scientific, expert-led government. An insistence upon the professional management of both government and the state bureaucracy has meant that a vast number of managers and experts have been appointed to positions that would formerly have been the responsibility of either a supposedly politically neutral civil service or of elected politicians. For some, this step has been interpreted to be little more than governance as usual within the UK; a Platonic rule by the country's elite guardians for the people, sustained by a web of secrecy, complexity, and sophistication that has served to ensure as little transparency as possible (see e.g., [135,[START_REF] Kavanagh | Political culture in Great Britain: The decline of the civic culture[END_REF]). From this perspective, the enduring common contempt of the political elite for hoi polloi, surviving the modern expansion of both the mass media and the provision of public education, has been matched only by their robust commitment to 'strong government'; a powerful, centralised executive that exerts flexible control over its party, and dominates both Houses of Parliament (to which the judiciary is subordinate) ([135]; indicatively, see also [102]).

It is a commonplace that analyses both of the 'democratic deficit' and cases of 'sleaze' are followed by an insistence upon the generally high standards of British public life. Weir and Beetham's [135] tome auditing the state of British democracy, for example, concludes that some corporate groups capture government departments and enjoy preferential access to political power; that management of public services is now largely in the hands of unelected groups ('quangos'-Quasi-Autonomous Non-Governmental Organisations); that membership of the second chamber of Parliament remains entirely dependent on inheritance, on holding other (unelected) office, or on executive appointment (rather than election); and that 'there are significant gaps in electoral reach, inequalities and limitations in electoral choice, partialities in electoral administration, and differential access to the electoral process and influence over it for different social groups', all of which 'seriously damage and neutralise what is at heart a recognisably democratic system of electoral accountability' (ibid.: 491). Weir and Beetham also discuss political party funding scandals of recent years (though many more have followed since their publication, theirs was an uncommon acknowledgement; compare [118:135]). And yet they confidently assert, without further explanation: '[i]t is true that British politics are almost certainly less corrupt than many similar liberal democracies' (ibid.: 94). In a similar vein, Leigh and Vulliamy's investigation into the hiring of members of parliament by business lobbyists to influence parliamentary and governmental business during the 1990s contains a significant caveat: a brief juxtaposition with the Italian political system during the same time, illustrating that '[t]here, the political system had become an edifice of corrupt patronage, based on kickbacks. Britain's politicians were minnows in this game by comparison' [84:149]. What explains such judgements?

In significant part, the belief that Britain is a relatively un-corrupt country appears predicated upon the relatively low level of reported experience and knowledge of pressure to pay bribes in order to gain access to routine public services, as found by international public opinion surveys (see [132,[START_REF] Hayward | Survey of public attitudes towards standards in public life[END_REF]). The low level of reported bribery practices in Britain is often explained by the fact that, as a wealthy state, it is able to pay officials sufficiently that they do not seek alternative supplementary income via requesting bribes (and furthermore, that such behaviour would be seen as unacceptably immoral and shamefully disrespectful of the public service ethos). This thesis has been weakened by the impact of competitive capitalism on British society which, as successive scandals involving the financial benefits accrued by members of both Houses of Parliament have illustrated, has rendered highly flexible the notion of 'sufficient pay'. Thus, for example, when in the 1990s some politicians were found to have been regularly taking payments for services (asking questions and lobbying in parliament), arguments were raised in their defence that politicians are over-worked and under-paid (e.g., in comparison to business executives) [START_REF] Leigh | Sleaze: The corruption of parliament[END_REF]. The argument resurfaced more recently in defence of those Peers (at least 139 of 735 in total) sustaining one or multiple consultancy positions, when several were accused of illegally selling their influence over the drafting of legislation. Similarly, it returned in the defence of parliamentarians (around 74 out of a total of 646 MPs) who appeared to have exploited their expenses allowance, boosting their regular salaries (of £63,000, approximately $98,500), to levels that would more favourably compare with those attained by other elite professionals. 18 In international comparison, relatively low levels of official reporting and prosecution of corruption cases have also appeared to substantiate Britain's reputation. Few cases of corruption are reported to the official British Audit Commission; between 1995/6 and 2003, an average of 43 cases of public corruption were reported per year (with annual losses due to corruption estimated to average 262,000, or around $521,000). According to the Audit Commission, an annual 18 See 'Revealed: 139 Peers act as paid consultants', The Independent, 27 January 2009; 'Revealed: Paid Peers tried to change laws 50 times', Sunday Times, 1 February 2009; 'The true patrons of this greed are an over-mighty Press', The Guardian, 14 May 2009. On salary alone, the household income of a British MP places them above 91 percent of the population; the average income that they receive, that combines salary and expenses, places them above the household income of 96 percent of the population (not taking into account second incomes from partners) ('How does your pay compare with an MP's?', BBC News Magazine, 28 May 2009). For an instructive historical perspective on the development of this issue, see [35: 201-203]. average of 21 people were prosecuted under corruption legislation between 1993 and 2003. Between 1998 and 2003, the Serious Fraud Office prosecuted only seven cases where corruption was the charge [START_REF] Hl | Report and evidence session on the Draft Corruption Bill, 2002-3[END_REF]. According to TI UK [START_REF] Cockroft | Corporate corruption: Challenges in a changing world[END_REF], no cumulative corruption prosecutions were made in Britain between 2000 and 2008, only 4 investigations in 2006, and 15 investigations in 2007. For some, this has reaffirmed belief in the general cleanliness of the British system (see also [START_REF] Doig | Corruption and misconduct in contemporary British politics[END_REF], for a longer historical assessment). In the face of planned revisions to UK corruption legislation (whose inadequacies had been criticised by the Law Commission [START_REF]Legislating the criminal code: Corruption[END_REF]), for instance, the Confederation of British Industry argued that the low number of prosecutions in the UK reflected positive British corporate practice and behaviour, rather than a weakness in the law. They thus predicted that stricter legislation would not result in a rise in prosecutions [START_REF] Cbi | Comments on the Home Office Consultation Paper 'Bribery: Reform of the Prevention of Corruption Act and SFO powers in cases of bribery and foreign officials[END_REF].

For others such as TI, however, the low level of corruption prosecutions in Britain has rather signalled a failure of official commitment to address the issue. Indeed, commentators from the media and non-governmental organisations have argued in recent years that acts which should be understood as corrupt have regularly taken place but have avoided definition as such by law and/or public discourse; an argument that is as pertinent internationally as it is domestically. For example, the Tax Justice Network and TI have both argued that the acceptability of 'tax avoidance' and tax havens has constituted a form of corruption, whose façade of legitimacy has been maintained by political and business elites who benefit from them, and because the UK's stature as a hub for international markets has allowed it to reinforce its own interpretations of legality (see [START_REF] Christensen | Mirror, mirror on the wall, who's the most corrupt of all?[END_REF]131], and [START_REF] Naylor | Hot money and the politics of debt[END_REF] for discussion of the broader relationship between international sources of power and 'dirty money'). Such critiques highlight the imperative of recognising the ways in which international and domestic power relations condition discourses and laws that in turn dictate dominant meanings assigned to the term 'corruption'.

More generally, perceptions of low corruption in the UK often appear to be grounded in a latent relativism shaped by what is known of the monetary value of corrupt transactions domestically and internationally (see also [START_REF] Holmes | Rotten states? Corruption, post-communism, and neoliberalism[END_REF]). Over the 1990s, for example, the owner of Harrods, Al Fayed, paid around £500,000 (a little under $1 million) for lobbyists and politicians to support his interests in Parliament, in one of the biggest scandals of the 'sleaze' decade in British politics [START_REF] Leigh | Sleaze: The corruption of parliament[END_REF]. More recent 'misdemeanours' exposed between 2007 and 2008 concerned the expenses claims of members of parliament involving tens of thousands of pounds per case, where the internally-accorded penalties of the House remained light [START_REF] Bell | The truth that sticks: New labour's breach of trust[END_REF]108]. A few individuals -such as former Prime Minister Tony Blair (see 'The mystery of Tony Blair's finances', The Guardian, 1 December 2009), Sir Peter Emery, Sir Michael Grylls, Sir Marcus Fox [START_REF] Eggers | MPs for sale? Returns to office in postwar British politics[END_REF], and Margaret Thatcher's son Mark [START_REF] Hollingsworth | Thatcher's fortunes: The life and times of Mark Thatcher[END_REF]-have appeared to successfully exploit their privileged status, making a fortune by bringing together business interests and political power. On the whole, however, patterns of enrichment by the majority of those in political life are less easily measurable. Whilst it is known that political power can furnish considerable financial rewards during a period in office (see [START_REF] Eggers | MPs for sale? Returns to office in postwar British politics[END_REF]), many of which are hard enough to track, the exchange of favours with business interests may often continue afterwards, whether via appointment to a company directorship or a consultancy position [120:146-7, 121, 29]. In terms of international comparison, these examples appear rather unsubstantial alongside the extravagant kleptocracies of those such as President Mobutu of Zaïre, who siphoned hundreds of thousands of pounds of national wealth in the 1980s [START_REF] Harris | Political corruption: In and beyond the nation state[END_REF], or General Sani Abacha, who looted an estimated $5 billion from the Nigerian Treasury during the 1990s [105]. It is thus more the rarity of publicised, or recorded, outrageously extravagant corrupt cash transactions, rather than the number of individuals suspected of engaging in corrupt activities, that appears most decisive in shaping perceptions of negligible corruption in British political life.

Bringing together local, comparative, and international analysis

Assessments of corruption in Britain commonly rely upon the thesis that established institutions and national affluence have conditioned an environment in which corruption is regarded as unacceptable. This reasoning leaves little scope for considering those dimensions of corruption that are often assumed to pertain only to states of the global periphery, such as cultures of gift exchange (see e.g. [95:98]). 19 It logically follows, but is nonetheless striking, that there is a dearth of systematic research into contemporary gift-giving practices amongst political, corporate, and media sectors in core Western states, although they are hardly insignificant in terms of either their protagonists or monetary value. 20 Corruption research has also tended to neglect the continuing relevance of nepotism, patronage, and hereditary privilege in the West (from state honours and political dynasties amongst the elite to higher education amongst the middle and upper classes) that also bind these worlds together. 21 Furthermore, insufficient attention has been paid to the ways in which corruption scandals appear to be so regularly and so successfully defused, often with the argument that they do not really bestow significant advantages for the individuals involved, or that they benefit abstract party political or national interests. 22 Including these factors in nationally-focused studies of Western societies would help to redress the present imbalances, and enhance the meaningfulness, of international comparative academic research. Aside from the obligation of according the same degree of critical scrutiny towards Western societies as to others, placing greater emphasis on the study of commonalities would enrich the effort to understand and explain different corruption practices across societies.

Just as the validity of comparative variables needs to be checked against domestic realities, so too nationally-focused studies can benefit from considering those presented in comparative research. For both levels of analysis, however, bias reduction requires the inclusion of an account of international and domestic power relations in shaping perceptions and practices of corruption. Accordingly, the use of perception indices needs to clarify whose perceptions are being recorded, yet avoid the fallacious presumption that perceptions necessarily vary according to socioeconomic class, or indeed that cross-class consensus affords more reliable testament to the reality of corruption practices on the ground [START_REF] Box | Power, crime, and mystification[END_REF]109], given the way in which alarmist or reassuring discourses may be internalised and reproduced by the 'losers' of a system in core and peripheral societies alike [107,120,135,[START_REF] Bracking | Corruption and development: The anti-corruption campaigns[END_REF]. Retiring negative analytical stereotypes would expand the scope for thinking about ways in which to combat corruption, encouraging reflection upon the implications of phenomena such as the wave of enthusiasm displayed in 2008 by Sierra Leoneans for paying their taxes (so much so that they proudly hung their tax receipts from necklaces). And this in a state ravaged by conflict, ranked the least developed in the world by the UN, and exposed in 2007 for being 'riddled with corruption'. 23 As recent events have made abundantly clear, it is high time that those theories of comparative corruption analysis which can only castigate and 'other', rather than positively explore and engage with the lessons and experiences of the global South, be discarded.

Since the primary focus here is central government and state bureaucracy, this paper refers interchangeably to the UK and Britain to denote the 'national', although the importance of national and regional differences within the UK are by no means denied.

What is meant here is the distinction between 'thin', superficially-defined variables, and 'thick', detailed, and grounded case-studies. On the distinction between 'thick' and 'thin' explanatory variables, see[START_REF] Geertz | The interpretation of cultures: Selected essays by Clifford Geertz[END_REF].

Compare Putnam, one of the foremost US theorists of civic culture, who has accepted Banfield's conceptualisation of 'amoral familism' for southern Italy[114], but has rejected the notion of a positive correlation between the decline of the family and a decline of civic culture in the US [113], as well as that of a necessarily negative correlation between familism and economic development in general[114].

Comparative corruption research and the British case

This thesis has been subject to the qualification that recently 'partially' democratised states may experience more corruption even than dictatorships, although better-established democratic practices do inhibit corruption[START_REF] Montinola | Sources of corruption: A cross-country study[END_REF].

Data from the Gallup International 50 th Anniversary Survey of 1997 was used to confirm that lower levels of corruption in former British colonies were perceived as such by their own citizens, complementing elite views contained in the corruption perceptions indices of TI(1996, 1997, 1998) and Business International (one survey from the early 1980s) [133:419,426].

La Porta et al.[START_REF] Porta | The quality of government[END_REF] measure government performance according to the following indicators: degree of government interventionism, public sector efficiency, public good provision, size of government, and political freedom.

At a general level of critique, see, for example,[START_REF] Bracking | Political development and corruption: Why 'right here, right now![END_REF] 126, 127]. Latitude is actually used as a negative correlate of corruption by[START_REF] Porta | The quality of government[END_REF], drawing on[START_REF] Landes | The wealth and poverty of nations: Why some are so rich and some so poor[END_REF], who go on to suggest that states in more temperate zones have more productive agriculture and healthier climates, enabling them to develop their economies, and possibly their institutions, as well. The suggested use of daily average temperatures as an indicator of corruption was made by Holmes[65:181] in sarcastic critique of the use of statistical correlations to predict or explain corruption in exactly this way.

See, similarly,[START_REF] Garland | The culture of control: Crime and social order in contemporary society[END_REF][START_REF] Matravers | Contemporary penality and psychoanalysis[END_REF], for domestic-focused discussion of criminal scapegoating stimulated by middleclass guilt and anxieties.

As with international trends, public trust in political institutions has fluctuated over the past decade in Britain, but trust in political parties has consistently remained least, and low; the Eurobarometer opinion survey of 2004 found that 78 percent of British respondents 'tend not to trust' political parties[132, 5:8-9].

The Church of England recognises Protestantism as but one of three of its founding traditions, alongside Catholicism and Liberalism[23]. Contra La Porta et al.[START_REF] Porta | The quality of government[END_REF], it was not established in opposition to state power but rather by state power, and remained closely aligned to both monarchy and government until at least the last half of the nineteenth century[130].

See Ferguson [44] for discussion of the distortions to political agendas provoked by the power of influential donors over political parties.

Mauss suggests that while some Western anthropologists may have been able to identify the principles of reciprocity underlying gift-giving in more 'primitive' societies, including their often important political dimensions, there has been a misplaced sense of confidence that similar power relations and rationales do not inhere in gift-giving within their own societies[START_REF] Mauss | The gift[END_REF]. It may be the case, as Douglas[START_REF] Douglas | Foreword: No free gifts[END_REF] seems to propose, that such blindness arises from a pious liberal desire to preserve the ideal of altruism as such. Alternatively, it may stem from a more instinctive sense of cultural narcissism, according to which 'our' gift-giving practices naturally seem to be genuinely altruistic and non-binding, as opposed to 'theirs'. Whichever the case, the need for persistent self-reflection upon comparable practices on the part of corruption researchers of 'core' Western states is evident (see[START_REF] Maclennon | Corruption in corporate America: Enron-before and after[END_REF]).

Notwithstanding the work of Doig over past decades (e.g.,[START_REF] Doig | Corruption and misconduct in contemporary British politics[END_REF]), academic literature has neglected the roll call of more recent scandals, such as the case involving a British Secretary of State for Culture, her husband (an international corporate lawyer and tax expert) and a gift (allegedly from Italian PM Berlusconi) of £408,000 (around $812,000) which paid off their mortgage in the space of a month (see[START_REF] Bell | The truth that sticks: New labour's breach of trust[END_REF]).

Available but uncommon studies that have addressed the relationship between meritocratic reforms, elites, patronage, and education in Britain, include those by[135,[START_REF] Kellner | The civil servants: An inquiry into Britain's ruling class[END_REF][START_REF] Doig | Corruption and misconduct in contemporary British politics[END_REF] 111, 103, 121] (the latter two being writers from the field of journalism). Notable recent work on this issue with regard to the US includes that by[START_REF] Bellow | In praise of nepotism: A natural history[END_REF] (also a writer from the field of journalism); and on the interconnected worlds of US elites and their international impact, [134].

For more on logics and techniques of accommodation, see[START_REF] Levi | Suite revenge? The shaping of folk devils and moral panics about white-collar crimes[END_REF] 115,[START_REF] Kaufmann | Legal Corruption[END_REF] 128]. Debates surrounding the 'Cash for Honours' scandal and the BAe/al-Yamamah affair are also instructive:[112,[START_REF] Ewing | The cost of giving and receiving: Donations to political parties in the United Kingdom[END_REF]; 'Goldsmith denies BAE cash claim', BBC News, 8 June 2007; 'The charges that could torpedo BAE', The Independent, 10 June 2007.

Acknowledgements I am grateful for the helpful comments on earlier drafts of this paper offered by members of the Staff Seminar Group of the Department of International Relations at the LSE, and by the anonymous reviewers of the journal. Particular thanks for extended feedback are due also to Leonidas Cheliotis, Kimberly Hutchings, Uli Sedelmeier, John Sidel, and Andrew Walter.


Serena Frau

Maria Font Pous

Maria Rosa Luppino

Anita Conforti

Maria Font
email: maria.font@ulss20.verona.it

S Frau Dialogo

Farmaci

M Font Pous

Risk Management Plans: are they a tool for improving drug safety?

Keywords: Risk management, Risk assessment, Safety management, Surveillance programs, Hazard, Postmarketing product surveillance

come

Background

Repeated incidents on drug safety have highlighted the weaknesses of the European pharmacovigilance system, relying mainly on the spontaneous reporting of adverse drug events. Stricter assessment before drug approval and more intensive post-marketing surveillance through alternative tools like randomised clinical trials, observational studies and use of registries could have prevented or limited such incidents [START_REF] Eichler | Safe drugs and the cost of good intentions[END_REF][START_REF] Garattini | Patients and the public deserve big changes in evaluation of drugs[END_REF]. From 2005, new European legislation has authorised regulatory agencies to require drug companies to submit, along with their application for marketing authorisation, a risk management plan comprising detailed commitments to post-marketing pharmacovigilance [START_REF] Eichler | Safe drugs and the cost of good intentions[END_REF].

A product Risk Management Plan (RMP) is defined as a plan identifying the risks associated with a medicinal product, methods of further clarifying the safety profile of a product, and tools designed to minimise the risk to individual patients in clinical practice [3]. Since the implementation of RMPs in Europe, only one publication has critically assessed their role in improving the safety of marketed drugs [START_REF] Giezen | Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval[END_REF].

The following paper is based on the risk/benefit assessment of new drugs marketed in Italy carried out by the drug information bulletin Dialogo sui Farmaci, a member of the International Society of Drug Bulletins (ISDB). The aim of the study is to describe the characteristics of RMPs for 15 drugs approved by the European Medicines Agency (EMA), and their impact on post-marketing safety issues.

Materials and methods

Among 90 drugs approved by the Committee for Medicinal Products for Human Use (CHMP) of the EMA between 2006 and 2007, we selected those that were marketed in Italy in 2007 and 2008 (i.e. 38 products). From these, we excluded orphan drugs (11), new associations (4), newly labelled indications (2), drugs for topical use (1) and 5 drugs that were not assessed by Dialogo sui Farmaci.

The remaining 15 drugs belong to the following therapeutic categories: The safety data available in the public domain of the European Public Assessment Report (EPAR) for these 15 drugs have been analysed and compared with the information contained in the summary of the Risk Management Plan published in the same document (EPAR) [START_REF]EPARs for authorised medicinal products for human use[END_REF]. The structure of a Risk Management Plan and the different sections of each part are described in Table 1.

In order to verify if the studies required in the RMP were ongoing or not, we consulted two databases of clinical studies registries (clinicaltrial.gov and the WHO register) up to June 2009, using the ID number of clinical studies reported in RMP, when available. With regard to the postmarketing changes published for safety reasons up to June 2009, we checked all type II modifications (major changes) contained in the Summary of Product Characteristics (SPC) introduced for safety reasons. These changes are available in the document "Steps taken after authorisation" of the EPAR. Moreover, we examined all the safety communications published by the EMA (like press releases or public statements) about the selected drugs [6].

Results

What did RMPs address?

While a total of 157 safety specifications had been determined for the 15 drugs assessed, the type of risk (defined as identified risk, potential risk or important missing information) was detailed for just 7 of them. Common activities included for all the 15 drugs were routine pharmacovigilance and SPC modifications. Additional Pharmacovigilance Activities (experimental or observational studies) and Additional Risk Minimisation Activities proposed for each drug are shown in Table 2. No additional pharmacovigilance activities (i.e. new safety studies) were found for two drugs: paliperidone and sitagliptin. Among the studies required for 13 drugs, many were not described or were not identifiable through an ID number: in fact only 5 of them were found in the clinical trial registries at least 2 years after approval of the drugs, as shown in Table 3. For 5 drugs, risk minimisation activities in the form of training activities were included for practitioners (3), for patients [START_REF] Eichler | Safe drugs and the cost of good intentions[END_REF] or for both [START_REF] Eichler | Safe drugs and the cost of good intentions[END_REF].

Post-marketing safety measures

After these drugs were marketed and up to June 2009, safety issues had emerged for 12 of them, leading to 39 type II variations in SPC, including new adverse effects, contraindications, warnings, interactions or other safetyrelated information. Nearly half of such variations, i.e. 19 (49%) of them, regarded new safety concerns not previously considered by the RMPs. Among the remaining 20 variations (51%), only 1 (entecavir and the risk of HVB virus resistance) resulted from a study reported in the RMP; 13 of these emerged from post-marketing studies not mentioned in the RMP (i.e. telbivudine and peripheral neuropathy, for which the RMP proposed only routine pharmacovigilance. This adverse effect motivated the publication of a public statement. Rotavirus vaccine and apnoea in premature infants and entecavir and HIV resistance were safety concerns not envisaged in their RMP). Finally, 6 modifications were due to routine pharmacovigilance.

In addition, 9 Safety Communications (SC: press releases or public statements) had been published for 6 out of 15 drugs assessed (Table 3). Two SCs reported events not previously included in the related RMPs of two drugs (two cases of death in subjects vaccinated with the tetravalent HPV vaccine, events not considered as causally related to the vaccine; entecavir and HIV-resistant strains in 3 patients with HIV co-infection).

Two further SCs concerned the risk of epoetins in patients with chronic kidney disease, which may be associated with an increased risk of mortality and cardiovascular morbidity. The RMP included a post-marketing safety study for thromboembolic events.

The remaining 5 SCs related to three drugs and reported safety concerns already included in the RMPs. Telvibudine was associated with peripheral neuropathy, varenicline with suicidal ideation and suicide attempts, and 3 SCs were issued for rimonabant. As regards rimonabant, the first SC contraindicated its use in patients with ongoing major depression or those treated with antidepressants and the other 2 SCs announced its suspension and subsequent withdrawal because of serious psychiatric events.

Pharmacovigilance activities foreseen in the RMPs of these three drugs were mainly routine pharmacovigilance. For rimonabant, an unspecified study was also included; the intensification of the psychiatric events described in the SC, however, was mainly based on case reports and cumulative reviews. No safety data emerged for 3 out of the 15 drugs assessed (anidulafungin, abatacept, bivalent HPV vaccine).

Discussion

How can RMPs improve pharmacovigilance ?

In order to "reinforce" routine pharmacovigilance, RMPs have included additional pharmacovigilance activities that go beyond spontaneous reports, such as new specific studies planned for safety reasons including observational ones, or monitoring safety aspects of ongoing clinical trials. These activities could provide stronger and more timely evidence on safety and speed up procedural steps for adequate measures to be taken. Among the Risk Minimisation Activities, information and training activities for practitioners and patients are new tools, different from SPC modifications, which could, at least theoretically, help to improve risk communication and consequently minimise harm caused by new drugs.

The real value of RMPs as a tool to identify, clarify and minimise risks can be estimated by comparing the clinical safety of each drug with the safety concerns considered and developed in the RMP (both available in the scientific discussion of the EPAR) at the time of drug approval. A second step compares the activities foreseen in the RMP (mainly additional pharmacovigilance activities and a risk minimisation plan) with the safety aspects that emerged in the post-marketing phase (SPC type II modifications for safety reasons and EMA safety communications). This analysis reveals several critical points about the way RMPs have been implemented and about their real value.

Several activities proposed by the RMPs do not appear to be adequate for dealing with the potential risks of drugs Pharmacovigilance activities foreseen in the RMP to address safety concerns appear inadequate for ascertaining the observed risks. Rimonabant is one such example, where psychiatric side effects, depression in particular, were a Identification of type of risk: in the Safety Specification section of each RMP, the type of risk surveyed should be classified as identified risk, potential risk or important missing information already identified as the main safety issues at the time of approval. The proposed activities considered in the RMP, among them an unspecified study, and further changes in the SPC, were inadequate for minimising a risk that caused its withdrawal 2 years later. Another example is varenicline: its RMP identified as safety concerns "adverse events associated with smoking cessation (which included depressed mood, insomnia, irritability/frustration/anger, restlessness, and concentration difficulties)", stating that "no attempt was made in the analysis of varenicline safety data to distinguish between the events associated with varenicline and those associated with nicotine withdrawal". For this safety issue, only routine pharmacovigilance was proposed. Three years after the launch of varenicline, 4 out of 6 SPC modifications were due to psychiatric events. Cardiac events such as increased incidence of atriumventricular block were observed with vildagliptin in both animal models and clinical studies. Although the EMA recommended that specific post-marketing studies on cardiovascular safety should be conducted, the approved RMP did not include any study to monitor heart-related adverse effects, but simply suggested routine pharmacovigilance activities.

Poor risk communication

Providing risk-related information is a crucial step: if safety information fails to reach health professionals and patients within adequate timeframes, the whole RMP system and pharmacovigilance itself will lose significance. The criteria whereby some pieces of information are addressed through SPCs change while others are the subject of public statements are unclear. The following examples illustrate the case.

At the time of exenatide approval, 40 cases of pancreatitis were observed, which progressively increased in number. Pancreatitis as well as acute renal damage are included as rare events in the SPC update, although no quantitative data are supplied. An SC might be more adequate for serious reactions such as these. Other Regulatory Agencies, such as the FDA in the USA or the MHRA (Medicines Healthcare products Regulatory Agency) in the UK, have published official communications through "Dear Healthcare Professional" letters or pharmacovigilance newsletters about such risks [START_REF] Mhra-Chm | Exenatide (Byetta): risk of severe pancreatitis and renal failure[END_REF]8].

Another example is rimonabant. Warnings such as the one against administering rimonabant to individuals with pre-existing depression or who are using antidepressants should have been issued as contraindications earlier; the same applies to epileptic patients. Repeated changes in warnings in the SPC do not seem to protect patients adequately.

Limited transparency

A major issue, which is also the main limitation of this study, is the lack of publically available data regarding the most significant aspects of the RMPs. Information is particularly lacking in the area of additional pharmacovigilance activities. The article by Giezen et al. [START_REF] Giezen | Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval[END_REF] assessed the RMP of 18 drugs (8 of them are the same as those analysed in this article). Having access to the study protocols foreseen in the RMP, the authors report that no one study had a complete protocol, 26% submitted a limited protocol, the remaining 74% had a study synopsis, a short description or just a commitment to perform a study. The educational programmes for doctors and patients are also lacking in any content. There is thus a tangible risk that these programmes could become a promotional tool instead of improving the safe use of drugs.

Other important data such as whether the drug has been submitted or not to the EMA regulatory authorities for scientific advice or protocol assistance in the evaluation process, before drug approval, are also lacking. According to Giezen et al., marketing authorisation applicants and regulators should have active discussions on postmarketing studies early in the evaluation process by way of scientific advice. However, major involvement of regulators in drug development, through scientific advice, could make CHMP decisions binding, thus making drug assessment less independent [START_REF] Garattini | Europe's opportunity to open up drug regulation[END_REF]. Minimal conditions for effective transparency on RMPs implies publically available data about the proposed pharmacovigilance activities, particularly full study protocols and clear timelines for their development, as well as more information on doctor and patient programmes.

New directions in European pharmacovigilance

The proposed Regulation and Directive of December 2008 concerning pharmacovigilance proposes, among many other measures, more widespread use of risk management systems, particularly if there are concerns about risks "affecting the risk-benefit balance of an authorised product and which should be proportioned to the risks" [10][11][START_REF]EU Commission's proposals on pharmacovigilance dismantle the entire system[END_REF]. According to the proposal, if concerns exist about the safety of a drug authorised for exceptional circumstances, a marketing authorisation can be granted provided that postauthorisation studies are conducted. However, as this report and a few other publications show, a large proportion of the studies required after drug approval are being conducted too late or simply not being carried out at all [START_REF] Avorn | Paying for drug approvals. Who's using whom?[END_REF]. The trend observed in recent years by the EMA, showing that many drug safety aspects that have not been duly clarified at the time of approval are being shifted to the post-marketing phase, does not appear to be adequately manageable through RMPs and consequently poses a danger to patients. Instead, more stringent pre-marketing evaluation should be required. Several other measures proposed in the new Regulation and Directive will weaken rather than strengthen the European Pharmacovigilance system, for instance, the creation of a Pharmacovigilance Risk Assessment Advisory Committee (PRAAC), not independent from the CHMP, which will continue to have the final responsibility for the risk-benefit assessment of medicinal products (article 9). Moreover, pharmacovigilance activities would be funded through the collection of fees charged to marketing authorisation holders (article 11) [11].

Conclusions

It seems too early to give a comprehensive assessment of RMP effectiveness as a pharmacovigilance tool, particularly based on the limited number of drugs assessed. RMPs, as they are implemented, are at risk of being another "cosmetic" intervention, with no real impact on the improvement of drug safety for European citizens.

Risk Management Plans could bring added value to pharmacovigilance provided that the main safety concerns are not deferred until the post-marketing phase, that additional pharmacovigilance activities are adequate for the proposed safety concerns and that post-marketing studies become mandatory for marketing authorisation holders. Besides this, greater transparency by the EMA in providing safety information for the public and for health professionals is now an absolute requirement [START_REF] Garattini | Patients and the public deserve big changes in evaluation of drugs[END_REF][START_REF] Garattini | Europe's opportunity to open up drug regulation[END_REF][START_REF] Garattini | How can we regulate medicines better?[END_REF].

1 .

 1 Drugs for the prevention of different risk factors: a) Antidiabetics: exenatide, vildagliptin, sitagliptin b) Smoking cessation: varenicline c) Antiobesity: rimonabant 2. Vaccines: tetravalent and bivalent HPV vaccine; Rotavirus vaccine 3. Anti-infective drugs: anidulafungin, entecavir, telbivudine 4. Biological drugs: abatacept; ranibizumab; methoxy polyethylene glycol epoetin beta (MPEG epoetin beta) 5. Others: paliperidone

Table 1

 1 Structure of a Risk Management Plan (RMP)

	Part I

Table 2

 2 Main features of the RMPs of the 15 drugs

	Drug	Therapeutic indication	Number	Required new studies in the RMP	Additional risk	Identification
			of RMP		minimisation	of type of
			safety		activities	risk a
			concerns
	Exenatide	Type II diabetes	10	4 clinical trials; meta-analyses from	No	No
				long-term studies in 2007 and 2009;
				1 database study
	Sitagliptin	Type II diabetes	10	No	No	Yes
	Vildagliptin	Type II diabetes	14	Total number of studies not specified:	No	No
				post-marketing epidemiological study;
				cohort observational study; clinical studies
	Varenicline	Smoking cessation	8	5 randomised clinical trials+1	No	Yes
				observational study
	Rimonabant	Obesity	16	Total number of studies not specified.	For practitioners Yes
				2 observational studies, 1 disease registry.
				Monitoring prescription
	Tetravalent	Prevention of pre-malignant	4	Pregnancy registry; post-marketing safety	No	No
	HPV	genital lesions, cervical		study; Norwegian vaccine study, Nordic
	vaccine	cancer and external genital		Cancer registry, adolescent cohort study
		warts related to HPV		and adolescent extension study
	Bivalent HPV	Prevention of pre-malignant	7	4 ongoing studies; 7 clinical trials;	No	Yes
	vaccine	cervical lesions and cervical		1 cohort study; 1 pregnancy register
		cancer causally related to HPV
	Rotavirus	Rotavirus immunisation	7	Post-marketing safety surveillance study;	No	No
	vaccine			1 clinical trial
	Anidulafungin Invasive candidiasis	10	3 clinical trials+2 observational studies	No	Yes
	Telbivudine	HVB	9	Ongoing and planned future studies	For practitioners Yes
				(not identified)
	Entecavir	HVB	7	4 new studies not specified; roll-over	No	No
				studies and large observational study;
				ongoing studies (not identified)
	Abatacept	Rheumatoid arthritis	11	2 new studies not specified, 5	For patients	Yes
				epidemiological studies; 2 registries
	MPEG	Anaemia associated with	10	Paediatric development programme	For practitioners No
	epoetin beta	CKD
	Ranibizumab	Age-related macular	6	3 observational studies	For patients and	No
		degeneration			practitioners
	Paliperidone	Schizophrenia	28	No	No	No

HPV, human papilloma virus; MPEG, methoxy polyethylene glycol ; HVB, hepatitis B virus; CKD, chronic kidney disease

Table 3

 3 Main safety changes after drug approval for the 15 drugs

	Drug	Studies found	SPC Type II	EMA Safety
		in clinical	safety	Communication:
		trials	modifications	public statement
		registries		or press release
	Exenatide	Yes	3	No
	Sitagliptin	No	3	No
	Vildagliptin	No	2	No
	Varenicline	Yes	6	14/12/2007
	Rimonabant	No	3	19/07/2007
				23/10/2008 a
				30/01/2009 a
	Tetravalent
	HPV vaccine

Acknowledgements Maria Font Pous (MFP) is an expert on drug information and former President of the International Society of Drug Bulletins (ISDB). Serena Frau (SF) is member of the editorial board of an independent drug bulletin that regularly assesses drugs. MFP and SF have designed the study and developed part of the analysis. Anita Conforti (AC) is an expert in pharmacovigilance in the Veneto Region and a reviewer for the WHO collaborating Center for International Drug Monitoring Center (Uppsala). Maria Rosa Luppino (MRL) is an expert in pharmacovigilance and drug information. AC and MRL developed part of the data analysis. All the authors have reviewed and approved the final draft. MFP is the guarantor.

SPC, Summary of Product Characteristics; EMA, European Medicines Agency a Suspended and withdrawn

Conflicts of interest None.