Dataset Information

Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries.

ABSTRACT: Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with duplicate independent coding of all data. Using an author-generated, semi-structured questionnaire, we collected information from each disclosure policy/code on: target industries, categories of healthcare professionals covered, scope of payments included, location and searchability of the disclosed data. Our analysis shows that although important improvements have been put in place in the past few years, significant gaps remain in disclosure requirements and their implementation. The situation differs substantially from country to country and the most striking differences are between governmental and self-regulatory approaches, especially with regard to the comprehensiveness of the disclosed data. In many cases, individuals can still opt out and reporting is incomplete, with common influential gifts such as food and drink excluded. Finally, in several countries data are only available as separate PDFs from companies, thus making the payment reports difficult to access and analyse. In order to overcome these gaps, minimum standards for disclosures should be implemented across Europe. All payments to healthcare professionals and organizations should be included, all health-related industries should be required to submit reports, and usability of disclosed data should be guaranteed.

SUBMITTER: Fabbri A

PROVIDER: S-EPMC6015505 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries.

Fabbri Alice A Santos Ancel la A Mezinska Signe S Mulinari Shai S Mintzes Barbara B

International journal of health policy and management 20180601 6

Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with duplicate independent coding of all data. Using an author-generated, semi-structured questionnaire, we co ...[more]

PMID: 29935127

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Project description:OBJECTIVES:To analyse the section of Disclosure UK that pertains to healthcare professionals (HCPs) in order to provide insight into the database's structure and content and suggest ways to improve its transparency. DESIGN AND PARTICIPANTS:Cohort study of drug companies and HCPs in the 2015 and 2016 versions of Disclosure UK. RESULTS:Companies report transfers of value (ToVs) to named HCPs or, where an HCP declines to consent, in aggregate. Only a limited number of variables describe the recipient HCP and the ToV, precluding refined analyses. In 2015, 107 companies reported 54 910 ToVs worth ?50 967 728. In 2016, 109 companies reported ToVs but spending decreased by 7.3%. The spending was concentrated: the top 10 spenders reported about 50% of the total value, with consultancy-related payments comprising over 70%, and the rest being costs for events. In 2015, 55.5% (30 478) of ToVs worth ?24 428 619 (47.9%) were disclosed at the individual HCP level, increasing to 64.5% (32 407) and ?28 145 091 (59.2%) in 2016. Despite increased individual-level disclosure in 2016, the median number of ToVs reported by each company at the individual level was only 57.7%, with 25% of companies reporting less than 38.6%. We found little agreement (62%-48% in 2015 and 46%-30% in 2016) between HCP consent rates that we calculated based on information in the database and those provided by companies. CONCLUSIONS:Key deficiencies in Disclosure UK include: insufficient information on payments and recipients, a relatively low HCP consent rate for individual-level disclosure, differences in consent rates across companies and payment types, and reporting ambiguities or inconsistencies. We employ these findings to develop recommendations for improving transparency, including an easily interpretable consent rate statistic that allows for comparison across years, firms and countries. If deficiencies remain unresolved, the UK should consider introducing legislation requiring mandatory disclosure to allow for adequate tracking of industry payments.

Project description:ImportanceTransparency of industry payments to physicians could engender greater public trust in physicians but might also lead to greater mistrust of physicians and the medical profession, adversely affecting the patient-physician relationship.ObjectiveTo examine the association between nationwide public disclosure of industry payments and Americans' trust in their physicians and trust in the medical profession.Design, setting, and participantsSurvey study using difference-in-difference analyses of a national longitudinal survey comparing changes in states where industry payments were newly disclosed by Open Payments with changes in states where payments information was already available because of state sunshine laws. The US population-based surveys were conducted in September 2014-shortly before the initial public disclosure of industry payments-and again in September 2016. Final analyses were conducted September through December 2018. Participants were adults 18 years and older (n = 1388).ExposuresNational public disclosure through Open Payments of payments made by pharmaceutical and medical device firms to physicians.Main outcomes and measuresWake Forest measure of trust in one's own physician and Wake Forest measure of trust in the medical profession.ResultsOf the 3542 original survey respondents, 2180 (61.5%) completed the second survey 2 years later, and 1388 named the same most frequently seen physician in both surveys. The mean age of respondents at the time of the first survey was 53 years, and 749 (54.0%) were women. Race/ethnicity was white in 76.6% (1063 of 1388) and non-Hispanic black in 8.0% (111 of 1388). Public disclosure of payments was associated with lower trust in one's own physician regardless of whether respondents knew their physicians had received payments (decrease in Wake Forest measure of trust in one's own physician of 0.56 point; 95% CI, -0.79 to -0.32 point; P < .001). Open Payments was also associated with lower trust in the medical profession (decrease in Wake Forest measure of trust in the medical profession of 0.35 point; 95% CI, -0.58 to -0.12 point; P = .004).Conclusions and relevanceNationwide public disclosure of industry payments may be associated with decreased trust in physicians and in the medical profession. More judicious presentation of payments information may counteract unintended negative trust and spillover consequences of public disclosure.

Project description:ObjectivesTo investigate the extent and nature of pharmaceutical industry payments related to fertility and assisted reproduction in Australia.Design and settingThis retrospective observational study employed four databases compiled from publicly available pharmaceutical industry transparency reports on educational event sponsorship (October 2011-April 2018), payments to healthcare professionals (October 2015-April 2018) and patient group support (January 2013-December 2017). Analyses were restricted to fertility-related payments by two major manufacturers of fertility medicines in Australia: Merck Serono and Merck, Sharp and Dohme (MSD).Primary and secondary outcome measuresDescriptive statistics on fertility-related payments and other transfers of value (counts, total and median costs in Australian dollars) for educational events and to healthcare professionals and patient groups.ResultsBetween October 2011 and April 2018, Merck Serono and MSD spent $A4 522 263 on 970 fertility-related events for healthcare professionals, including doctors, nurses and fertility scientists. 56.8% (551/970) events were held by fertility clinics and 29.3% (284/970) by professional medical associations. Between October 2015 and April 2018, Merck Serono spent $A403 800 across 177 payments to 118 fertility healthcare professionals, predominantly for educational event attendance. Recipients included obstetricians and gynaecologists (76.3% of payments, 135/177), nurses (11.3%, 20/177) and embryologists/fertility scientists (9.6%, 17/117). The highest paid healthcare professionals held leadership positions in major fertility clinics. Merck Serono provided $A662 850 to fertility-related patient groups for advocacy and education (January 2013-December 2017).ConclusionsThe pharmaceutical industry sponsored a broad range of fertility clinicians and organisations, including doctors, nurses, embryologists, professional medical organisations, fertility clinics and patient groups. This sponsorship may contribute to the overuse of fertility services.

Project description:ImportanceDrug company payments to health care organizations can create conflicts of interest. However, little is known about such financial relationships, especially outside the United States.ObjectiveTo examine the concentration and patterns of drug company payments to health care organizations in the United Kingdom.Design, setting, and participantsThis cross-sectional study examined nonresearch payments reported in the industry-run Disclosure UK database. Companies participating in Disclosure UK in 2015 and health care organizations receiving their payments were included in the analysis. The data were analyzed descriptively at the health care organization, payment, and donor levels, considering health care organization categories, payment categories, and companies from February 5 through May 28, 2017, with follow-up checks from June 1 through August 31, 2018. Analysis was conducted from July 10 through December 20, 2018.Main outcomes and measuresShare of funding and the Gini index (GI) to measure payment concentration (0 indicates perfect deconcentration [eg, all drug companies provide the same value of payments]; 1, perfect concentration [eg, 1 company provides the entire value of payments]) and median and interquartile range (IQR) to measure payment patterns.ResultsA total of 4028 health care organizations received 19 933 payments, worth US $72 110 156.6, from 100 companies. This study identified 11 categories of health care organizations, with 3-public-sector secondary and tertiary care providers, education and research providers, and professional organizations-accumulating 67.2% of funding. The health care organization categories had varying GIs (range, 0.65-0.92), medians (range, $750.3-$45 862.4), and IQRs (range, $389.1-$1843.9 to $3104.4-$199 868.2). Of 4 payment categories, the top category-donations and grants-captured 50.6% of funding. Joint working (collaborative projects with nonindustry partners) had a lower GI (0.64) than other payment categories (range, 0.79-0.84). The median and IQR were the lowest for contributions to costs of events ($366.8; IQR, $229.3-611.3) and highest for joint working ($14 903.7; IQR, $3185.0-34,748.4). The top 10 firms (58.6% of funding) had payments with varying medians (from $366.8 [IQR, $244.5-611.3] to $9781.3 [IQR, $1834.0-48 906.7]).Conclusions and relevanceAlthough organizations from across the health care system received funding, the payments were concentrated on a few large donors, payments, and recipients. Different payment and recipient categories had different patterns of payment values, suggesting that the industry has diversified its funding strategies across different parts of the health care system. These results suggest that Disclosure UK requires improved transparency, particularly by including built-in recipient categories, and that organizational conflicts of interest need more policy attention, including disclosure of payments independent of the industry.

Project description:BackgroundFinancial ties between physicians and the pharmaceutical and medical device industry are common, but little is known about how patient trust is affected by these ties.ObjectiveThe purpose of this study was to evaluate how viewing online public disclosure of industry payments affects patients' trust ratings for physicians, the medical profession, and the pharmaceutical and medical device industry.DesignThis was a randomized experimental evaluation.ParticipantsThere were 278 English-speaking participants over age 18 who had seen a healthcare provider in the previous 12 months who took part in the study.InterventionsParticipants searched for physicians on an online disclosure database, viewed payments from industry to the physicians, and assigned trust ratings. Participants were randomized to view physicians who received no payment ($0), low payment ($250-300), or high payment (>$13,000) from industry, or to a control arm in which they did not view the disclosure website. They also were asked to search for and then rate trust in their own physician.Main measuresPrimary outcomes were trust in individual physician, medical profession, and industry. These scales measure trust as a composite of honesty, fidelity, competence, and global trust.Key resultsCompared to physicians who received no payments, physicians who received payments over $13,000 received lower ratings for honesty [mean (SD): 3.36 (0.86) vs. 2.75 (0.95), p < 0.001] and fidelity [3.19 (0.65) vs. 2.89 (0.68), p = 0.01]. Among the 7.9% of participants who found their own physician on the website, ratings for honesty and fidelity decreased as the industry payment to the physician increased (honesty: Spearman's ρ = -0.52, p = 0.02; fidelity: Spearman's ρ = -0.55, p = 0.01). Viewing the disclosure website did not affect trust ratings for the medical profession or industry.ConclusionsDisclosure of industry payments to physicians affected perceptions of individual physician honesty and fidelity, but not perceptions of competence. Disclosure did not affect trust ratings for the medical profession or the pharmaceutical and medical device industry. ClinicalTrials.gov identifier: NCT02179632 ( https://clinicaltrials.gov/ct2/show/NCT02179632 ).

Dataset Information

Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries.

Publications

Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries.

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