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.

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.

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.

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.

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.

Advancing international comparison of pharmaceutical industry funding of patient advocacy: Focus on Denmark.

Pharmaceutical industry funding of patient organizations raises ethical challenges related to patient engagement in healthcare due to fears of commercial agendas influencing patient advocacy and creating industry-driven inequalities across patient organizations. We contribute to an international body of knowledge on patient organization-industry relations by analyzing all payments reported by companies in Denmark over a six-year period, 2014-2019. We performed descriptive analyses calculating the number, value, and distribution of payments for various units of analysis: all companies and patient organizations; individual companies and patient organizations; and the broader disease area (e.g., cancer) and narrower disease (e.g., breast cancer). Fifty-one companies reported paying €8,826,916 to 84 patient organizations. As in previously studied countries, the funding was dominated by a relatively small number of funders and recipients, and commercially high-profile diseases attracted most of the funding. Nevertheless, our study also highlighted the arguably concerning dominance of one company in Denmark, both at the level of overall funding and in funding specific patient organizations, during a time of great policy contention surrounding one of its drugs, the world's top-selling medicine; i.e., switching patients to cheaper biosimilars to save big money for the healthcare system. Patient organizations have reasons to rethink some collaborations with companies, especially during policy contentions, and governments should ensure equitable funding to counteract risks posed by the concentration of industry funding.

The making of a Swedish strategy: How organizational culture shaped the Public Health Agency's pandemic response.

Several suggestions have been made as to why Sweden's approach to managing the COVID-19 pandemic came to rely on a strategy based on voluntary measures. Two of the most prominent explanations for why the country chose a different strategy than many other countries have focused on micro- and macro-level factors, explaining the strategy either in terms of the psychologies of prominent actors or by pointing to particularities in Swedish constitutional law. Supported by a qualitative analysis using interviews and text analysis, we argue that the Swedish strategy cannot be understood without paying attention to the meso-level and the organizations that produced the strategy. Moreover, we argue that to understand why one of the central organizations in Swedish pandemic management, the Public Health Agency, came to favor certain interventions, one must investigate the culture of production inside the organization and how it created precedents that led the Agency to approach pandemic management with a focus on balancing current and future health risks.

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.

Tip of the Iceberg? Country- and Company-Level Analysis of Drug Company Payments for Research and Development in Europe.

BACKGROUND: Creating new therapies often involves drug companies paying healthcare professionals and institutions for research and development (R&D) activities, including clinical trials. However, industry sponsorship can create conflicts of interest (COIs). We analysed approaches to drug company R&D payment disclosure in European countries and the distribution of R&D payments at the country and company level. METHODS: Using documentary sources and a stakeholder survey we identified country- regulatory approaches to R&D payment disclosure. We reviewed company-level descriptions of disclosure practices in the United Kingdom, a country with a major role in Europe's R&D. We obtained country-level R&D payment data from industry trade groups and public authorities and company-level data from eurosfordocs.eu, a publicly available payments database. We conducted content analysis and descriptive statistical analysis. RESULTS: In 32 of 37 studied countries, all R&D payments were reported without named recipients, following a self-regulatory approach developed by the industry. The methodological descriptions from 125 companies operating in the United Kingdom suggest that within the self-regulatory approach companies had much leeway in deciding what activities and payments were considered as R&D. In five countries, legislation mandated the disclosure of R&D payment recipients, but only in two were payments practically identifiable and analysable. In 17 countries with available data, R&D constituted 19%-82% of all payments reported, with self-regulation associated with higher shares. Available company-level data from three countries with self-regulation suggests that R&D payments were concentrated by big funders, and some companies reported all, or nearly all, payments as R&D. CONCLUSION: The lack of full disclosure of R&D payments in countries with industry self-regulation leaves considerable sums of money unaccounted for and potentially many COIs undetected. Disclosure mandated by legislation exists in few countries and rarely enhances transparency practically. We recommend a unified European approach to R&D payment disclosure, including clear definitions and a centralised database.

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.

Accessibility and quality of drug company disclosures of payments to healthcare professionals and organisations in 37 countries: a European policy review.

OBJECTIVES: To examine the accessibility and quality of drug company payment data in Europe. DESIGN: Comparative policy review of payment data in countries with different regulatory approaches to disclosure. SETTING: 37 European countries. PARTICIPANTS: European Federation of Pharmaceutical Industries and Associations, its trade group and their drug company members; eurosfordocs.eu, an independent database integrating payments disclosed by companies and trade groups; regulatory bodies overseeing payment disclosure. MAIN OUTCOME MEASURES: Regulatory approaches to disclosure (self-regulation, public regulation, combination of the two); data accessibility (format, structure, searchability, customisable summary statistics, downloadability) and quality (spectrum of disclosed characteristics, payment aggregation, inclusion of taxes, recipient or donor identifiers). RESULTS: Of 30 countries with self-regulation, five had centralised databases, with Disclosure UK displaying the highest accessibility and quality. In 23 of the remaining countries with self-regulation and available data, disclosures were published in the portable document format (PDF) on individual company websites, preventing the public from understanding payment patterns. Eurosfordocs.eu had greater accessibility than any industry-run database, but the match between the value of payments integrated in eurosfordocs.eu and summarised separately by industry in seven countries ranged between 56% and 100% depending on country. Eurosfordocs.eu shared quality shortcomings with the underlying industry data, including ambiguities in identifying payments and their recipients. Public regulation was found in 15 countries, used either alone (3), in combination (4) or in parallel with (8) self-regulation. Of these countries, 13 established centralised databases with widely ranging accessibility and quality, and sharing some shortcomings with the industry-run databases. The French database, Transparence Santé, had the highest accessibility and quality, exceeding that of Disclosure UK. CONCLUSIONS: The accessibility and quality of payment data disclosed in European countries are typically low, hindering investigation of financial conflicts of interest. Some improvements are straightforward but reaching the standards characterising the widely researched US Open Payments database requires major regulatory change.

Drug company payments to General Practices in England: Cross-sectional and social network analysis.

Although there has been extensive research on pharmaceutical industry payments to healthcare professionals, healthcare organisations with key roles in health systems have received little attention. We seek to contribute to addressing this gap in research by examining drug company payments to General Practices in England in 2015. We combine a publicly available payments database managed by the pharmaceutical industry with datasets covering key practice characteristics. We find that practices were an important target of company payments, receiving £2,726,018, equivalent to 6.5% of the value of payments to all healthcare organisations in England. Payments to practices were highly concentrated and specific companies were also highly dominant. The top 10 donors and the top 10 recipients amassed 87.9% and 13.6% of the value of payments, respectively. Practices with more patients, a greater proportion of elderly patients, and those in more affluent areas received significantly more payments on average. However, the patterns of payments were similar across England's regions. We also found that company networks-established by making payments to the same practices-were largely dominated by a single company, which was also by far the biggest donor. Greater policy attention is required to the risk of financial dependency and conflicts of interests that might arise from payments to practices and to organisational conflicts of interests more broadly. Our research also demonstrates that the comprehensiveness and quality of payment data disclosed via industry self-regulatory arrangements needs improvement. More interconnectivity between payment data and other datasets is needed to capture company marketing strategies systematically.

Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU.

Recent decades have seen much interest in racial and ethnic differences in drug response. The most emblematic example is the heart drug BiDil, approved by the US Food and Drug Administration in 2005 for "self-identified blacks." Previous social science research has explored this "racialization of pharmaceutical regulation" in the USA, and discussed its implications for the "pharmaceuticalization of race" in terms of reinforcing certain taxonomic schemes and conceptualizations. Yet, little is known about the racialization of pharmaceutical regulation in the USA after BiDil, and how it compares with the situation in the EU, where political and regulatory commitment to race and ethnicity in pharmaceutical medicine is weak. We have addressed these gaps by investigating 397 product labels of all novel drugs approved in the USA (n = 213) and the EU (n = 184) between 2014 and 2018. Our analysis considered statements in labeling and the racial/ethnic categories used. Overall, it revealed that many labels report race/ethnicity demographics and subgroup analyses, but that there are important differences between the USA and the EU. Significantly more US labels specified race/ethnicity demographics, as expected given the USA's greater commitment to race and ethnicity in pharmaceutical medicine. Moreover, we found evidence that reporting of race/ethnicity demographics in EU labels was driven, in part, by statements in US labels, suggesting the spillover of US regulatory standards to the EU. Unexpectedly, significantly more EU labels reported differences in drug response, although no drug was restricted to a racial/ethnic population in a manner similar to BiDil. Our analysis also noted variability and inconsistency in the racial/ethnic taxonomy used in labels. We discuss implications for the racialization of pharmaceutical regulation and the pharmaceuticalization of race in the USA and EU.

Pharmaceutical industry self-regulation and non-transparency: country and company level analysis of payments to healthcare professionals in seven European countries.

The European pharmaceutical industry uses the alleged efficacy of self-regulation to question the need for transparency laws similar to the US Physician Payment Sunshine Act. We conducted a comparative analysis of 20 large companies' payment disclosures in seven European countries in 2017-2019. The data was extracted as part of eurosfordocs.eu, a novel transparency project that scrapes and integrates publicly available databases and disclosures. Our analysis of EUR 735 million showed marked differences in country payment patterns. For example, payment totals per registered doctor were substantially larger in Spain and lowest in Sweden. There were significant country and company differences in individualized data completeness. Only 19% of totals were reported with recipient names in Germany, compared to Ireland (59%), the United Kingdom (60%), Italy (67%), Switzerland (73%), Sweden (79%) and Spain (100%), with little or no improvement over time. Payment data in Spain was particularly difficult to extract. Thus, in no country did self-regulation generate comprehensive individualized data allowing for building an accurate picture of financial relationships between the industry and healthcare professionals. We conclude that the cultures and policies of countries and companies create structural problems of data inaccessibility and incompleteness within the self-regulatory framework. Therefore, this study supports calls for a Europe-wide "Sunshine Act" to achieve real transparency of drug company payments.

Under-reported relationship: a comparative study of pharmaceutical industry and patient organisation payment disclosures in the UK (2012-2016).

OBJECTIVES: To examine the under-reporting of pharmaceutical company payments to patient organisations by donors and recipients. DESIGN: Comparative descriptive analysis of payments disclosed on drug company and charity regulator websites. SETTING: UK. PARTICIPANTS: 87 donors (drug companies) and 425 recipients (patient organisations) reporting payments in 2012-2016. MAIN OUTCOME MEASURES: Number and value of payments reported by donors and recipients; differences in reported payments from/to the same donors and recipients; payments reported in either dataset but not the other one; agreement between donor-recipient ties established by payments; overlap between donor and recipient lists and, respectively, industry and patient organisation data. RESULTS: Of 87 donors, 63 (72.4%) reported payments but 84 (96.6%) were mentioned by recipients. Although donors listed 425 recipients, only 200 (47.1%) reported payments. The number and value of payments reported by donors were 259.8% and 163.7% greater than those reported by recipients, respectively. The number of donors with matching payment numbers and values in both datasets were 3.4% and 0.0%, respectively; for recipients these figures were 7.8% and 1.9%. There were 24 and 3 donors missing from industry and patient organisation data during the entire study period, representing 38.1% and 3.6% of those in the respective datasets. The share of donor-recipient ties in which industry and patient organisation data agreed about donors and recipients was 38.9% and 68.4% in each dataset, respectively. Of 63 donors reporting payments, only 3 (4.8%) had their recipient lists fully overlapping with patient organisation data. Of 200 recipients reporting industry funding, 102 (51.0%) had their donor lists fully overlapping with industry data. CONCLUSIONS: Both donors and recipients under-reported payments. Existing donor and recipient disclosure systems cannot manage potential conflicts of interest associated with industry payments. Increased standardisation could limit the under-reporting by each side but only an integrated donor-recipient database could eliminate it.

Five years of pharmaceutical industry funding of patient organisations in Sweden: Cross-sectional study of companies, patient organisations and drugs.

BACKGROUND: Many patient organisations collaborate with drug companies, resulting in concerns about commercial agendas influencing patient advocacy. We contribute to an international body of knowledge on patient organisation-industry relations by considering payments reported in the industry's centralised 'collaboration database' in Sweden. We also investigate possible commercial motives behind the funding by assessing its association with drug commercialisation. METHODS: Our primary data source were 1,337 payment reports from 2014-2018. After extraction and coding, we analysed the data descriptively, calculating the number, value and distribution of payments for various units of analysis, e.g. individual companies, diseases and payment goals. The association between drug commercialisation and patient organisation funding was assessed by, first, the concordance between leading companies marketing drugs in specific diseases and their funding of corresponding patient organisations and, second, the correlation between new drugs in broader condition areas and payments to corresponding patient organisations. RESULTS: 46 companies reported paying €6,449.224 (median €2,411; IQR €1,024-4,569) to 77 patient organisations, but ten companies provided 67% of the funding. Small payments dominated, many of which covered costs of events organised by patient organisations. An association existed between drug commercialisation and industry funding. Companies supported patient organisations in diseases linked to their drug portfolios, with the top 3 condition areas in terms of funding-cancer; endocrine, nutritional and metabolic disorders; and infectious and parasitic disorders-accounting for 63% of new drugs and 56% of the funding. CONCLUSION: This study reveals close and widespread ties between patient organisations and drug companies. A relatively few number of companies dominated the funding landscape by supporting patient organisations in disease areas linked to their drug portfolios. This commercially motivated funding may contribute to inequalities in resource and influence between patient organisations. The association between drug commercialisation and industry funding is also worrying because of the therapeutic uncertainty of many new drugs. Our analysis benefited from the existence of a centralised database of payments-which should be adopted by other countries too-but databases should be downloadable in an analysable format to permit efficient and independent analysis.