Dataset Information

Voluntary disclosures of payments from pharmaceutical companies to healthcare professionals in Germany: a descriptive study of disclosures in 2015 and 2016.

ABSTRACT: OBJECTIVE:To analyse voluntary payment reports of pharmaceutical companies to German healthcare professionals (HCPs) in 2015 and 2016 based on an industry-self-regulating transparency codex. DESIGN AND PARTICIPANTS:Cohort study of all German HCPs who voluntarily agreed that at least one payment they received in 2015 and 2016 from pharmaceutical companies is disclosed. MAIN OUTCOME MEASURES:Number of HCPs who disclosed at least one payment in the database; separated by year of disclosure and whether they disclosed once or repeatedly. Amount of disclosed payments and distribution parameters of disclosed annual payment sums per person; separated by year of disclosure und whether they disclosed once or repeatedly. RESULTS:28 230 HCPs agreed to the disclosure of at least one payment in the database. In 2015, 19 905 HCPs agreed to the disclosure, decreasing to 15 782 HCPs in 2016. Whereas 7457 disclosed payments in both years, 12 448 disclosed only in 2015 and 8325 only in 2016. Payments of €32 426 721 in 2015 and €23 289 343 in 2016 were disclosed, that is, 27% and 23% of the total amounts spent on HCPs, respectively. Distribution of annual payments was skewed: the top 1% of HCPs disclosed annual payment sums between €17 049 and €200 194, while the median disclosed annual payment sum per person was €536 (IQR €1092). Disclosed payments were higher in male physicians and in physicians with higher academic degree. CONCLUSIONS:If voluntary, disclosure rates of payments are low and therefore only provide a fragmented picture of interactions between HCPs and pharmaceutical companies. Efforts must be intensified to ensure obligatory disclosure of all payments worldwide.

SUBMITTER: Stoll M

PROVIDER: S-EPMC7500304 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Voluntary disclosures of payments from pharmaceutical companies to healthcare professionals in Germany: a descriptive study of disclosures in 2015 and 2016.

Stoll Marlene M Hubenschmid Lara L Koch Cora C Lieb Klaus K

BMJ open 20200917 9

<h4>Objective</h4>To analyse voluntary payment reports of pharmaceutical companies to German healthcare professionals (HCPs) in 2015 and 2016 based on an industry-self-regulating transparency codex.<h4>Design and participants</h4>Cohort study of all German HCPs who voluntarily agreed that at least one payment they received in 2015 and 2016 from pharmaceutical companies is disclosed.<h4>Main outcome measures</h4>Number of HCPs who disclosed at least one payment in the database; separated by year ...[more]

PMID: 32948560

Similar Datasets

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:ObjectivesTo investigate German physicians' attitudes towards and experiences with voluntary disclosure of payments by pharmaceutical companies in a public database and their impact on future decisions for or against disclosure.DesignA national cross-sectional survey conducted in 2018 among physicians who voluntarily disclosed at least one payment in the German transparency regulation.SettingRetrospective paper-pencil questionnaire about attitudes towards and experiences with voluntary payment disclosures in the first (2015) and second (2016) years of the German transparency regulation.ParticipantsGerman physicians who disclosed either in the first year only, the second year only, or in both years of the transparency regulation.Primary outcomes(1) The probability to disclose in 2016, predicted by physicians' experience of reactions from others in 2015, descriptive norms and attitudes towards transparency; (2) Frequency and (3) Content of reactions from others in 2015 compared with 2016.ResultsData of 234 respondents were analysed (n=42, 45 and 147 physicians who disclosed in 2015, 2016 or both years, respectively). The probability to disclose in 2016 was not predicted by perceived reactions, norms or attitudes towards transparency (p>0.01). Most participants reported not to have received any reactions by patients (190/234, 81%), colleagues (128/234, 55%) or the private environment (153/234, 65%). Neither frequency nor content of reactions differed between the first and second years (scale 1-5; frequency: Mdn 2015,2016 = 1.33 vs 1.00, r b=-0.17, p>0.01; content: Mdn 2015,2016 = 3.00 vs 3.00, r b=0.19, p>0.01). However, media reporting, fear of reputational damage and a feeling of being defamed were mentioned as reasons for non-disclosure.ConclusionsWhile confirmatory analyses did not provide significant results, descriptive analyses showed that participants who voluntarily disclose payments mainly do not experience any reactions towards their disclosures but report fears about losing their reputation due to disclosures.

Project description:BackgroundOncologists who author clinical practice guidelines frequently have financial relationships with the pharmaceutical industry. It is unknown whether participation on clinical practice guideline committees is associated with differences in the amounts of industry money received.Materials and methodsWe conducted a nested case-control study from August 2013 to December 2018. We manually abstracted membership records of National Comprehensive Cancer Network (NCCN) Guidelines committees for the 20 most common cancers and linked to Open Payments. The study sample included medical oncologists selected to join an NCCN Guidelines committee ("joiners") during the study period. Joiners were matched 1:2 to medical oncologists who had no participation on NCCN committees (controls) by gender, NCCN institution, and medical school graduation year. We performed difference-in-differences (DiD) estimation to assess whether selection to an NCCN committee was associated with the dollar value of payments received from industry, using generalized estimating equations to address correlation between matched pairs and between repeated observations of the same pair.ResultsDuring the study period, 54 physicians joined an NCCN Guidelines committee. These physicians received more payments than matched controls in the year prior to joining ($11,259 vs. $3,427; p = .02); this difference did not increase in the year after joining (DiD = $731; p = .45).ConclusionMedical oncologists selected to NCCN Guidelines committees had greater financial ties to industry than their peers. The potential influence of industry in oncology clinical practice guidelines may be reduced through the selection of committee members with fewer ties to industry.Implications for practiceOncologists who author clinical practice guidelines frequently have financial conflicts of interest with the pharmaceutical industry. This creates concern about the potential for industry influence on guidelines. However, it is unknown whether oncologists who author guidelines have greater industry relationships than their peers. This study compared medical oncologists who were newly selected to join a National Comprehensive Cancer Network (NCCN) Guidelines panel with medical oncologists at the same institutions and at similar career stages. At the time they joined, oncologists joining NCCN Guidelines panels had received more than three times the dollar value of industry payments than their peers. The potential for industry influence may be reduced by the selection of less-conflicted panel members.

Project description:Importance:Financial relationships between pharmaceutical companies and physicians can bias the conduct, findings, and reporting of clinical trials. In Japan, the valsartan scandal was a significant event: all 5 key articles on the valsartan clinical trials were retracted after the revelation of data falsification. Consequently, the Japan Pharmaceutical Manufacturers Association issued transparency guidelines, and pharmaceutical payments have been publicly disclosed since 2013. However, the distribution of payments from pharmaceutical companies among authors involved in the valsartan scandal after its revelation has not been studied to date. Objective:To identify the characteristics and distribution of payments from pharmaceutical companies to researchers involved in the valsartan scandal in Japan by using a comprehensive payment database. Design, Setting, and Participants:This retrospective cross-sectional study, conducted from January 1, 2016, through September 30, 2017, used information on payments from 78 pharmaceutical companies to 50 authors of 5 articles retracted after the valsartan scandal: the Kyoto Heart Study, Jikei Heart Study, SMART (Shiga Microalbuminuria Reduction Trial), VART (Valsartan Amlodipine Randomized Trial), and Nagoya Heart Study. Payments from companies to physicians were analyzed during the period from January 1, 2016, to September 30, 2017. Main Outcomes and Measures:The main outcomes were the amount and proportion of payments made by pharmaceutical companies to authors, and the forms of these payments. Results:Of 50 eligible authors, 30 (60%) received payments from pharmaceutical companies in 2016. The payments in the Japanese yen totaled ¥67.15 million (US $590 896) and the mean (SD) payment was more than ¥1.34 million (¥3.01 million) (US $11 817 [$27 292]). Five authors (10%) received more than ¥5 million (US $44 000) and 3 authors (6%) received more than ¥10 million (US $88 000). The total payments to the corresponding author of each article was ¥29 million (US $255 307), accounting for 43.2% of the total payments. Regarding forms of the payments, lecture fees accounted for 81.3% of the total payment (¥54.56 million). Conclusions and Relevance:Many authors involved in the valsartan scandal received payments from the pharmaceutical industry. Although whether such payments to these authors have decreased since the scandal is unclear, the findings appear to demonstrate that their financial relationships with the industry are still prominent. The findings of the study appear to support the need to encourage more transparency in such relationships because misconduct can occur within unclear relationships.

Project description:ImportanceClinical practice guidelines (CPGs) are important in advancing the quality of medical care. Financial relationships between physicians and pharmaceutical companies may influence clinical practice. In accordance with the Japan Pharmaceutical Manufacturers Association guidelines for transparency, pharmaceutical company payments to physicians have been disclosed since 2013. The distribution of pharmaceutical company payments among CPG authors in Japan has not been studied.ObjectivesTo determine the characteristics and distribution of payments made by pharmaceutical companies to authors of oncologic CPGs in Japan and to assess the transparency of policies associated with conflict of interest (COI) disclosures in CPGs.Design, setting, and participantsThis retrospective cross-sectional study of 326 authors from 6 prominent oncologic CPGs from Japan included annual payment data for 2016 from 78 pharmaceutical companies during varying times from January 1, 2016, through September 30, 2017.Main outcomes and measuresAmount and proportion of payments made by pharmaceutical companies to the authors; amount and proportion of payments made to the authors of each guideline; and information on policies for disclosing COIs in CPGs (Japanese yen were converted to US dollars based on the February 20, 2019 exchange rate of 110 yen per 1 US dollar).ResultsOf 326 eligible authors, 255 (78.2%) received payments from pharmaceutical companies in 2016. The total number of payments was 3947, and the total amount was $3 444 193 (¥378 861 220), including $2 696 777 for speaking, $181 944 for writing, $554 381 for consulting, and $11 091 for unclear fees. The median payment amount was $3233 (interquartile range [IQR], $506-$10 873), and the mean (SD) payment amount was $10 565 ($20 059); 84 authors (25.8%) received more than $10 000. The largest proportions of CPG authors receiving at least 1 payment were those for gastric carcinoma (92%) and colorectal carcinoma (92%). The median payment was highest for authors of colorectal carcinoma guidelines ($7781; IQR, $2506-$18 633), whereas it was lowest for authors of pancreatic carcinoma guidelines ($2207; IQR, $304-$9240). Only breast carcinoma CPGs published the authors' individual COI disclosure in an identifiable matter; guidelines for lung, colorectal, pancreatic, and hepatocellular carcinomas disclosed the financial relationships between the authors and companies anonymously; and the gastric carcinoma CPGs did not have a COI disclosure section.Conclusions and relevanceMost oncologic CPG authors received payments from pharmaceutical companies, and COI disclosure methods appeared to be insufficient. Given the possibility of bias in guideline content if authors have any financial relationships with pharmaceutical companies, CPGs from Japan may require improved transparency.

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:ObjectivesTo examine the accessibility and quality of drug company payment data in Europe.DesignComparative policy review of payment data in countries with different regulatory approaches to disclosure.Setting37 European countries.ParticipantsEuropean 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 measuresRegulatory 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).ResultsOf 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.ConclusionsThe 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.

Dataset Information

Voluntary disclosures of payments from pharmaceutical companies to healthcare professionals in Germany: a descriptive study of disclosures in 2015 and 2016.

Publications

Voluntary disclosures of payments from pharmaceutical companies to healthcare professionals in Germany: a descriptive study of disclosures in 2015 and 2016.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets