Race in clinical trials in Sweden: How regulatory and medical standards in clinical research trump the post-racial discourse.

The post-racial discourse that permeates many Western European countries depicts society as having moved beyond race concepts and classifications. This article focuses on Sweden, a country that, in line with the post-racial thinking, declares race to be an offensive and unscientific concept. The article investigates what happens when this post-racial discourse meets clinical research standards that encourage, if not demand, the collection of data on patient race. Through an analysis of the reporting of patient race in 76 multinational trials with at least one study site in Sweden, and a review of the regulatory and medical standards and trial documents that direct the collection of patient race in trials, we show how race classification is kept intact in trials despite conflicting with post-racial norms and conventions. Notably, our findings diverge from the way racialisation is typically assumed to work in Sweden and related countries. We argue this is possible because the two incompatible understandings of race are 'distributed' (Mol, 2002, The body multiple: Ontology in medical practice, Duke University Press) among different social worlds. The distribution, we propose, is upheld through the paucity of major debate on why and how race classification should be carried out in clinical trials in Europe as this allows contradictions to remain unspoken.

International comparison of pharmaceutical industry payment disclosures in the UK and Japan: implications for self-regulation, public regulation, and transparency.

BACKGROUND: Self-regulation of payment disclosure by pharmaceutical industry trade groups is a major global approach to increasing transparency of financial relationships between drug companies and healthcare professionals and organisations. Nevertheless, little is known about the relative strengths and weaknesses of self-regulation across countries, especially beyond Europe. To address this gap in research and stimulate international policy learning, we compare the UK and Japan, the likely strongest cases of self-regulation of payment disclosure in Europe and Asia, across three dimensions of transparency: disclosure rules, practices, and data. RESULTS: The UK and Japanese self-regulation of payment disclosure had shared as well unique strengths and weaknesses. The UK and Japanese pharmaceutical industry trade groups declared transparency as the primary goal of payment disclosure, without, however, explaining the link between the two. The rules of payment disclosure in each country provided more insight into some payments but not others. Both trade groups did not reveal the recipients of certain payments by default, and the UK trade group also made the disclosure of some payments conditional on recipient consent. Drug company disclosure practices were more transparent in the UK, allowing for greater availability and accessibility of payment data and insight into underreporting or misreporting of payments by companies. Nevertheless, the share of payments made to named recipients was three times higher in Japan than in the UK, indicating higher transparency of disclosure data. CONCLUSIONS: The UK and Japan performed differently across the three dimensions of transparency, suggesting that any comprehensive analysis of self-regulation of payment disclosure must triangulate analysis of disclosure rules, practices, and data. We found limited evidence to support key claims regarding the strengths of self-regulation, while often finding it inferior to public regulation of payment disclosure. We suggest how the self-regulation of payment disclosure in each country can be enhanced and, in the long run, replaced by public regulation to strengthen the industry's accountability to the public.

A 'patient-industry complex'? Investigating the financial dependency of UK patient organisations on drug company funding.

We examined the minimum extent of dependency of UK patient organisations on pharmaceutical industry funding using drug company disclosure reports and patient organisation financial accounts from 2012 to 2016. We used linear regression to explain the overall share of industry funding ('general dependency') and top donor funding ('company-specific dependency') in organisations' income. Predictors included patient organisations' goal; having members and volunteers; geographical scope of activity; headquarter location; expenditure/income ratio; and disease area. The prevalent low levels of general dependency (IQR, 0.1%-6.0%) and company-specific dependency (IQR, 0.1%-4.3%) made a widespread capture of patient organisations unlikely, though only if one excludes the possibility of significant payment under-reporting. However, organisations with considerably higher dependency than others might be more prone to co-optation by industry. Of the 398 organisations, 18 (4.5%) and 8 (2.0%) had general and company-specific financial dependency over 50%, respectively. However, the shares of outliers exceeding the third quartile plus 1.5 times IQR were 51 (12.8%) and 56 (14.1%) for each dependency type. Certain characteristics including activity profile (advocacy) or indicating limited access to resources (remote location) made organisations vulnerable to developing financial dependency. Future research should examine both financial and non-financial links between the two sides and their impact on patient organisations' activity.

Content and strength of conflict of interest policies at Scandinavian medical schools: a cross sectional study.

BACKGROUND: Concerns around staffs' and students' interactions with commercial entities, for example drug companies, have led several North American medical schools to implement conflict of interest (COI) policies. However, little is known about COI policies at European medical schools. We analysed the content and strength of COI policies at Scandinavian medical schools. METHODS: We searched the websites of medical schools in Denmark, Norway, and Sweden and emailed the Deans for additional information. Using comparable methodology to previous studies, the strength of the COI policies was rated on a scale from 0 to 2 across 11 items (higher score more restrictive); we also assessed the presence of oversight mechanisms and sanctions. RESULTS: We identified 77 unique policies for 15 medical schools (range 2-8 per school). Most of the policies (n = 72; 94%) were University wide and only five (6%) were specific for the medical schools. For six of eleven items one or more schools had a restrictive policy (score of two). None of the schools had a restrictive policy for the five additional items (speaking relationships, sales representatives, on-site education activities, medical school curriculum, and drug samples). Honoraria was the item with the highest score, with eight of the 15 schools having a score of two. Thirteen of the 15 schools had policies that identified a party responsible for policy oversight and mentioned sanctions for non-compliance. CONCLUSION: Our study provides the first evaluation of all Scandinavian medical schools' COI policies. We found that the content of COI policies varies widely and still has shortcomings. We encourage Scandinavian medical schools to develop more stringent COI policies to regulate industry interactions with both faculty and students.

Revisiting the pharmaceuticalisation of pandemic influenza using Lukes' framework of power.

The power of social actors to drive or block pharmaceutical uptake has been a concern in sociological debates on pharmaceuticalisation, including in the case of pandemic vaccination. We build on Steven Lukes' three-dimensional view of power to explore the 2009 H1N1 pandemic vaccination in Sweden and Denmark - two similar countries that arrived at conflicting vaccination strategies. Drawing on interviews with members of each country's pandemic steering group and on document analysis, we explore three consecutive stages of pandemic vaccination response: planning, vaccine procurement and the vaccination campaign. The paper makes two contributions to studies of pharmaceuticalisation and pandemics. Conceptually, we advocate the suitability of Lukes' framework over the 'countervailing powers' framework repeatedly used to model power in the pharmaceutical field. Empirically, our study confirms that government-appointed experts steered pandemic planning in both countries, but we show that the state, industry and the WHO also exerted power by enabling and constraining experts' decision-making, including by keeping some information secret. Furthermore, we argue that mass vaccination in Sweden was a pervasive expression of state power, in Lukes' sense, since it rested on keeping latent the tension between many individuals' health interests and the state's interests in protecting social and economic functioning.

Sociodemographic patterns in pharmacy dispensing of medications for erectile dysfunction in Sweden.

PURPOSE: The purpose of this study is to investigate the relationship between sociodemographic factors and pharmacy dispensing of medications for erectile dysfunction (ED) in the general population of middle-aged and elderly men. By considering a number of medical conditions that could promote or contraindicate use of ED medication, the analysis could help capture prescription patterns that might not be explained by medical needs. METHODS: Individual-level pharmacy dispensing data from 2006 for a population-based cohort of 216,148 men aged 45-79 years in the county Scania, Sweden, were analysed. Multiple logistic regression was applied, and area under the receiver operating characteristic curve (AUC) was calculated to quantify the discriminatory accuracy (DA) of the associations. National trends in pharmacy dispensing of ED medication between 2006 and 2016 were also analysed. RESULTS: Pharmacy dispensing of ED medication increased between 2006 and 2016, particularly among men aged 65-79 years (from 6.8 to 9.2%). Dispensing of ED medication was positively associated with higher socioeconomic position, and divorced and widowed men were more likely to fill a prescription with ED medication than married men. These associations remained after adjusting for medical conditions. The DA of the associations was, however, rather low (AUC = 0.69 among 45-64 year olds and AUC = 0.65 among 65-79 year olds). CONCLUSIONS: Pharmacy dispensing of ED medication seem linked to the individuals socioeconomic position, age and marital status suggesting sociodemographic disparities in the pharmacy dispensing targeting sexual function. However, the low DA of the associations shows the limited capacity of these factors to predict ED medication use at the individual level.

Pharmaceutical lobbying and pandemic stockpiling of Tamiflu: a qualitative study of arguments and tactics.

Background: Little is known about how pharmaceutical companies lobby authorities or experts regarding procurement or the use of vaccines and antivirals. This paper investigates how members of Denmark's pandemic planning committee experienced lobbying efforts by Roche, manufacturer of Tamiflu, the antiviral that was stockpiled before the 2009 A(H1N1) pandemic. Methods: Analysis of interviews with six of seven members of the Danish core pandemic committee, supplemented with documentary analysis. We sought to identify (1) arguments and (2) tactics used in lobbying, and to characterize interviewees' views on the impact of (3) lobbying and (4) scientific evidence on the decision to stockpile Tamiflu. Results: Roche lobbied directly (in its own name) and through a seemingly independent third party. Roche used two arguments: (1) the procurement agreement had to be signed quickly because the drug would be delivered on a first-come, first-served basis and (2) Denmark was especially vulnerable to an influenza crisis because it had smaller Tamiflu stocks than other countries. Most interviewees suspected that lobbying had an impact on Tamiflu procurement. Conclusions: Our study highlights risks posed by pharmaceutical lobbying. Arguments and tactics deployed by Roche are likely to be repeated whenever many countries are negotiating drug procurements in a monopolistic market.

Regulatory scientists' work has important ramifications for public health and should be open to public scrutiny.

The Swedish Medical Products Agency (MPA) objects to the fact that we occasionally refer to one of its senior ex-employees by name. However, names of individual MPA assessors, Food and Drug Administration (FDA) reviewers, and European Medicines Agency rapporteurs and co-rapporteurs are cited in regulatory documents and are a matter of public record. In our paper (Health Res Policy Syst 15:93, 2017), we in no way suggest that regulatory decisions were left to individual reviewers or assessors, although we do emphasise that individual MPA and FDA employees' scientific assessments and benefit-risk evaluations are critical to the decision-making process. In this response to the MPA, we raise a further issue - one in which the question of personal identification of individuals is relevant - and this pertains to the accountability of influential scientists and experts who contribute to public policy decisions with important ramifications for public health. In our view, it is important that interested observers are able to identify those influential individuals, and entirely appropriate that their work should be open to public scrutiny.

Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of 'deep' product reviews.

BACKGROUND: Relenza represents the first neuraminidase inhibitor (NI), a class of drugs that also includes the drug Tamiflu. Although heralded as breakthrough treatments in influenza, NI efficacy has remained highly controversial. A key unsettled question is why the United States Food and Drug Administration (FDA) has approved more cautious efficacy statements in labelling than European regulators for both drugs. METHODS: We conducted a qualitative analysis of United States and European Union regulatory appraisals for Relenza to investigate the reasons for divergent regulatory interpretations, pertaining to Relenza's capacity to alleviate symptoms and reduce frequency of complications of influenza. RESULTS: In Europe, Relenza was evaluated via the so-called national procedure with Sweden as the reference country. We show that FDA reviewers, unlike their European (i.e. Swedish) counterpart, (1) rejected the manufacturer's insistence on pooling efficacy data, (2) remained wary of subgroup analyses, and (3) insisted on stringent statistical analyses. These differences meant that the FDA was less likely to depart from prevailing regulatory and scientific standards in interpreting trial results. We argue that the differences are explained largely by divergent institutionalised review methodologies, i.e. the European regulator's reliance on manufacturer-compiled summaries compared to the FDA's examination of original data and documentation from trials. CONCLUSIONS: The FDA's more probing and meticulous evaluative methodology allowed its reviewers to develop 'deep' knowledge concerning the clinical and statistical facets of trials, and more informed opinions regarding suitable methods for analysing trial results. These findings challenge the current emphasis on evaluating regulatory performance mainly in terms of speed of review. We propose that persistent uncertainty and knowledge deficits regarding NIs could have been ameliorated had regulators engaged in the public debates over the drugs' efficacy and explained their contrasting methodologies and judgments. Regulators use major resources to evaluate drugs, but if regulators' assessments are not effectively disseminated and used, resources are used inefficiently.

Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.

BACKGROUND: European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. METHODS AND FINDINGS: We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However, while the UK cases typically related to only one or a few claims made in printed material, several complaints in the US alleged multifaceted and covert marketing activities. Because this study is limited to PMCPA rulings and whistleblower-initiated federal cases, it may offer a partial view of exposed off-label marketing. CONCLUSION: The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion.

Testosterone prescribing in the population-a short social epidemiological analysis in Sweden.

PURPOSE: In recent years, there has been an increased interest for use of pharmaceutical testosterone among elderly men. However, it is still scarcely studied if this use is conditioned by socioeconomic factors in the general population of elderly men. METHODS: Using individual-level data from a population-based cohort of men aged 65-84 years in the County Scania, Sweden, we analysed testosterone use in 2006 in relation to demographic and socioeconomic factors by means of multiple logistic regression. We also analysed national data at the ecological level to investigate trends in prescribing between 2006 and 2014. RESULTS: The prevalence of testosterone use in Sweden among 65- to 84-year-old men increased by 83%, from 3.3 per 1000 men in 2006 to 6.0 in 2014. Testosterone use was more than twice as common in men in the highest income quintile compared with those in the lowest (0.68% versus 0.25%, odds ratio 2.69 and 95% confidence interval 1.80-4.02). Besides in the high-income group, testosterone use was highest in 65- to 69-year-old men, divorced men and, specially, in men with a previous hospital diagnose of hypogonadism. CONCLUSIONS: Our findings show socioeconomic inequities in prescription of testosterone. This is a short analysis based on limited data, but because information on this topic is scarce, our analysis adds a relevant piece of evidence and highlights the need for further research.

Appropriate assessment of ethnic differences in adolescent use of psychotropic medication: multilevel analysis of discriminatory accuracy.

OBJECTIVE: In the present study, we used a multilevel approach to investigate the role of maternal country of birth (MCOB) in predicting adolescent use of psychotropic medication in Sweden. DESIGN: Using the Swedish Medical Birth Register we identified all 428,314 adolescents born between 1987 and 1990 and who were residing in Sweden in the year they turned 18. We applied multilevel logistic regression analysis with adolescents (level 1) nested within MCOBs (level 2). Measures of association (odds ratio) and measures of variance (intra-class correlation (ICC)) were calculated, as well as the discriminatory accuracy by calculating the area under the Receiver Operator Characteristic (AU-ROC) curve. RESULTS: In comparison with adolescents with Swedish-born mothers, adolescents with mothers born in upper-middle, lower-middle and low-income countries were less likely to use psychotropic medication. However, the variance between MCOBs was small (ICC = 2.5 in the final model) relative to the variation within MCOBs. This was confirmed by an AU-ROC value of 0.598. CONCLUSIONS: Even though we found associations between MCOB and adolescent use of psychotropic medication, the small ICC and AU-ROC indicate that MCOB appears to be an inaccurate context for discriminating adolescent use of psychotropic medication in Sweden.

Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry self-regulation.

BACKGROUND: In many European countries, medicines promotion is governed by voluntary codes of practice administered by the pharmaceutical industry under its own system of self-regulation. Involvement of industry organizations in policing promotion has been proposed to deter illicit conduct, but few detailed studies on self-regulation have been carried out to date. The objective of this study was to examine the evidence for promotion and self-regulation in the UK and Sweden, two countries frequently cited as examples of effective self-regulation. METHODS AND FINDINGS: We performed a qualitative content analysis of documents outlining the constitutions and procedures of these two systems. We also gathered data from self-regulatory bodies on complaints, complainants, and rulings for the period 2004-2012. The qualitative analysis revealed similarities and differences between the countries. For example, self-regulatory bodies in both countries are required to actively monitor promotional items and impose sanctions on violating companies, but the range of sanctions is greater in the UK where companies may, for instance, be audited or publicly reprimanded. In total, Swedish and UK bodies ruled that 536 and 597 cases, respectively, were in breach, equating to an average of more than one case/week for each country. In Sweden, 430 (47%) complaints resulted from active monitoring, compared with only two complaints (0.2%) in the UK. In both countries, a majority of violations concerned misleading promotion. Charges incurred on companies averaged €447,000 and €765,000 per year in Sweden and the UK, respectively, equivalent to about 0.014% and 0.0051% of annual sales revenues, respectively. One hundred cases in the UK (17% of total cases in breach) and 101 (19%) in Sweden were highlighted as particularly serious. A total of 46 companies were ruled in breach of code for a serious offence at least once in the two countries combined (n = 36 in the UK; n = 27 in Sweden); seven companies were in serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations) and urologics (UK, n = 6; Sweden, n = 13; 9%) revealed various types of violations: misleading claims (n = 23; 58%); failure to comply with undertakings (n = 9; 23%); pre-licensing (n = 7; 18%) or off-label promotion (n = 2; 5%); and promotion of prescription drugs to the public (n = 6; 15%). Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct. CONCLUSIONS: The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias.

Questioning the discriminatory accuracy of broad migrant categories in public health: self-rated health in Sweden.

BACKGROUND: Differences between natives and migrants in average risk for poor self-rated health (SRH) are well documented, which has lent support to proposals for interventions targeting disadvantaged minority groups. However, such proposals are based on measures of association that neglect individual heterogeneity around group averages and thereby the discriminatory accuracy (DA) of the categories used (i.e. their ability to discriminate the individuals with poor and good SRH, respectively). Therefore, applying DA measures rather than only measures of association our study revisits the value of broad native and migrant categorizations for predicting SRH. DESIGN, SETTING AND PARTICIPANTS: We analyzed 27,723 individuals aged 18-80 who responded to a 2008 Swedish public health survey. We performed logistic regressions to estimate odds ratios (ORs), predicted risks and the area under the receiver operating characteristic curve (AU-ROC) as a measure of epidemiological DA. RESULTS: Being born abroad was associated with higher odds of poor SRH (OR = 1.75), but the AU-ROC of this variable only added 0.02 units to the AU-ROC for age alone (from 0.53 to 0.55). The AU-ROC increased, but remained unsatisfactorily low (0.62), when available social and demographic variables were included. CONCLUSIONS: Our results question the use of broad native/migrant categorizations as instruments for forecasting individual SRH. Such simple categorizations have a very low DA and should be abandoned in public health practice. Measures of association and DA should be reported together whenever an intervention is being considered, especially in the area of ethnicity, migration and health.

Regulating drug information in Europe: a pyrrhic victory for pharmaceutical industry critics?

Informed by recent sociological debates on pharmaceuticalisation, this article examines the evolution of the current EU legal proposal on prescription drug information to patients, as well as the surrounding controversies. In 2008 the European Commission proposed the relaxation of the existing rules governing drug information provision to patients by the pharmaceutical industry. Critics of the industry's influence over health policy and markets, including consumer organisations, industry-independent patient organisations and health professionals, rejected the Commission's proposal, claiming that the industry cannot be considered a reliable source of patient information due to inherent financial conflicts of interest. Since these critics were at least partially successful in rallying opinion against the Commission proposal, they functioned as countervailing forces to promotion-driven pharmaceuticalisation. Even so, as a watered-down version of the proposal moved through the European Parliament it was further modified to ultimately resemble the Swedish system that was held up as a high-quality example of industry-based information provision. Yet this article contends that the Swedish system displays evidence of corporate bias. Significantly, basing EU policy on a drug information system not resistant to corporate bias risks creating practices that violate the legally mandated mission of EU drug regulation, which is to 'promote and protect public health'.

Conceptual unclarity about COVID-19 ethnic disparities in Sweden: Implications for public health policy.

The COVID-19 pandemic has shed light on abundant racial and ethnic health disparities in many countries around the world. In Sweden, statistics on COVID-19 mortality and morbidity from both the first and the second wave of the pandemic show that foreign-born individuals have been disproportionately affected, compared to Swedish-born individuals. However, as demonstrated in this article, key stakeholders including politicians, public authorities, mainstream media, and medical researchers do not draw on the same explanatory framework when conceptualizing the health disparity. Probing the different discourses that were articulated through oral and written accounts during the first wave, the article identifies three different frameworks of how ethnic health disparities in relation to COVID-19 were understood in Sweden: the socioeconomic framework, the culturalist framework and the biological framework. We discuss the importance of our findings for health policy and argue for continued interrogation of epidemiological knowledge production from a critical vantage point in order to successfully combat health inequalities.

Pharmaceutical industry payments to NHS trusts in England: A four-year analysis of the Disclosure UK database.

INTRODUCTION: Although hospitals are key health service providers, their financial ties to drug companies are little understood. We examine non-research pharmaceutical industry payments to English National Health Service (NHS) trusts-hospital groupings providing secondary and tertiary care. METHODS: We extracted data from the industry-run Disclosure UK database, analysing it descriptively and using the Jonckheere-Terpstra test to establish whether a statistically significant time trend existed in the median values of individual payments. We explained payment value and number per trust with random effects models, using selected trust characteristics as predictors. RESULTS: Drug companies reported paying £60,253,421 to 234 trusts, representing between 90.0% and 92.0% of all trusts in England between 2015 and 2018. As a share of payments to all healthcare organisations, the number of payments rose from 38.6% to 39.5%, but their value dropped from 33.0% to 23.6%. The number of payments for fees for service and consultancy and contributions to costs of events increased by 61.5% and 29.4%. The median payment value decreased significantly for trusts overall (from £2,250.8 to £1,758.5), including those with lower autonomy from central government; providing acute services; and from half of England's regions. The random effects model showed that acute trusts received significantly more money on average than trusts with all other service profiles; and trusts from East England received significantly less than those from London. However, trusts enjoying greater autonomy from government did not receive significantly more money than others. Trusts also received significantly less money in 2018 than in 2015. CONCLUSION: NHS trusts had extensive pharmaceutical industry ties but were losing importance as payment targets relative to other healthcare organisations. Industry payment strategies shifted towards events sponsorship, consultancies, and smaller payments. Trusts with specific service and geographical profiles were prioritised. Understanding corporate payments across the health system requires more granular disclosure data.

Hedgehog, but not Odd skipped, induces segmental grooves in the Drosophila epidermis.

The formation of segmental grooves during mid embryogenesis in the Drosophila epidermis depends on the specification of a single row of groove cells posteriorly adjacent to cells that express the Hedgehog signal. However, the mechanism of groove formation and the role of the parasegmental organizer, which consists of adjacent rows of hedgehog- and wingless-expressing cells, are not well understood. We report that although groove cells originate from a population of Odd skipped-expressing cells, this pair-rule transcription factor is not required for their specification. We further find that Hedgehog is sufficient to specify groove fate in cells of different origin as late as stage 10, suggesting that Hedgehog induces groove cell fate rather than maintaining a pre-established state. Wingless activity is continuously required in the posterior part of parasegments to antagonize segmental groove formation. Our data support an instructive role for the Wingless/Hedgehog organizer in cellular patterning.

Disclosure of Pharmaceutical Industry Funding of Patient Organisations in Nordic Countries: Can Industry Self-Regulation Deliver on its Transparency Promise?

Pharmaceutical companies regularly fund patient organizations. It is important for patient organizations' credibility that there be transparency regarding this financial support. In Europe, the pharmaceutical industry promises to deliver transparency through self-regulation, as opposed to legally binding provisions, but self-regulation's effectiveness is contested. We compared the industry's transparency of funding in four Nordic countries that, given their general reputation for high transparency, offered a critical test of self-regulation's ability to deliver on its transparency promise. For 2017-2019, we compared: national rules regarding funding disclosure; disclosure practices as evidenced by the availability, accessibility, and format of company transparency reports; and disclosure data, including payment descriptions and sums. Transparency problems differed in kind and magnitude between countries. In Norway and Finland, unlike in Sweden and Denmark, data on funding were difficult to access and analyze and sometimes seemed incomplete or missing. We explain that a key factor allowing for country differences is the freedom given to a country's pharmaceutical industry trade associations to form self-regulatory rules, provided they do not fall below the weak, European-level minimum requirements. Transparency could be improved by aligning rules and practices with the FAIR data principles: that is, corporate disclosures should be findable, accessible, interoperable, and reusable.