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Pharmaceutical company payments to dermatology Clinical Practice Guideline authors in Japan.

ABSTRACT: Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296 CPGs authors, 269 authors (90.6%) received at least one payment from the Pharma. The total monetary value of payments for the 2-year period was $7,128,762. The median and mean monetary value of payments from the Pharma reporting were $10,281 (interquartile range $2,796 -$34,962) and $26,600 (standard deviation $40,950) for the two years combined. Of the 26 CPG authors who disclosed FCOIs due to the monies received from Pharma, only the atopic dermatitis CPG authors and the acne vulgaris CPG authors published their potential FCOIs. In Japan, most dermatology CPG authors received financial payments from Pharma. The transparency of the CPGs, as reported by the CPG authors, was inadequate, and a more rigorous framework of reporting and monitoring FCOI disclosure is required to improve the accuracy and transparency with relation to possible Conflicts of Interest.

SUBMITTER: Murayama A

PROVIDER: S-EPMC7553305 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Pharmaceutical company payments to dermatology Clinical Practice Guideline authors in Japan.

Murayama Anju A Ozaki Akihiko A Saito Hiroaki H Sawano Toyoaki T Shimada Yuki Y Yamamoto Kana K Suzuki Yosuke Y Tanimoto Tetsuya T

PloS one 20201013 10

Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCO ...[more]

PMID: 33048952

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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:Importance:It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. Objective:To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Design, Setting, and Participants:Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Main Outcomes and Measures:Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Results:Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10?000, and 18 accepted more than $50?000. Financial payments amounted to a mean of $157?177 per author. The total reimbursement among the 49 authors from 2013 to 2015 was $7?701?681. Of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. Authors received payments from companies with products directly related to the guideline topic. Violations to the Administrative Regulations were found. Conclusions and Relevance:Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments. The American Academy of Dermatology policies may benefit from stricter enforcement or the adoption of new standards.

Project description:ImportancePayments from pharmaceutical and device manufacturers to physicians may influence the advice physicians give patients and peers.ObjectivesTo investigate the nature and amounts of monetary and other benefits that gastroenterologists received and to determine the participation of those receiving benefits in the formulation of clinical practice guidelines.Design, setting, and participantsThis cohort study analyzed information from the Centers for Medicare & Medicaid Services Open Payments database, including all reports about payments that pharmaceutical and device manufacturers gave to adult or pediatric gastroenterologists in 2016. PubMed was used to examine the professional affiliations and publication records of top payment recipients. Panelists of clinical guidelines who also received personal financial rewards listed in the Open Payments database were identified.Main outcomes and measuresPayments made to gastroenterologists by pharmaceutical company and device manufacturers.ResultsOf 15 497 gastroenterologists, 13 467 (86.9%) received a total of 432 463 payments accounting for a total expenditure of $67 144 862. Direct financial payments for consultations, talks, or other services were made to 2055 physicians and were responsible for 4.2% of payments (18 179 of 432 463), but for 62.7% of total expenditures ($42 086 207 of $67 144 862). Although a significant number of submissions were for food and beverages, they constituted only a small amount of total expenditure. For gastroenterologists treating adult patients, 10 products were linked to 63.8% of payments (11 221 of 17 588) related to direct financial rewards and 37.1% of the total expenditures ($24 892 643 of $67 144 862). Twenty-nine of 36 clinical practice guidelines included panelists who had received honoraria or consultation fees from industry sources, with amounts exceeding $10 000 in 8 of them (22%).Conclusions and relevanceMost gastroenterologists accept meals or gifts from industry, with 2055 of 15 497 gastroenterologists receiving direct payments and 8 of 36 clinical practice guidelines panelists having received more than $10 000. Considering the known impact of such benefits on prescribing patterns and other professional behaviors, policy makers should consider revising regulations governing interactions with industry and disclosure formats alerting others to their potential biasing impact.

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:ObjectivesTo examine the characteristics of pharmaceutical payments to healthcare and patient organisations in the four UK countries. Compare companies spending the most; types of organisations receiving payments and types of payments in the four countries. Measure the extent to which companies target payments at the same recipients in each country and whether it differs depending on the type of recipient.DesignCross-sectional comparative and social network analysis.SettingEngland, Scotland, Wales, Northern Ireland.Participants100 donors (pharmaceutical companies) reporting payments to 4229 recipients (healthcare organisations and patient organisations) in 2015.Main outcome measuresFor each country: payment totals and distribution; average number of common recipients between companies; share of payments to organisations fulfilling different roles in the health ecosystem and payments for different activities.ResultsCompanies prioritised different types of recipient and different types of activity in each country. There were significant differences in the distribution of payments across the four countries, even for similar types of recipients. Recipients in England and Wales received smaller individual payments than in Scotland and Northern Ireland. Overall, targeting shared recipients occurred most frequently in England, but was also common in certain pockets of each country's health ecosystem. We found evidence of reporting errors in Disclosure UK.ConclusionsOur findings suggest a strategic approach to payments tailored to countries' policy and decision-making context, indicating there may be specific vulnerabilities to financial conflicts of interest at subnational level. Payment differences between countries may be occurring in other countries, particularly those with decentralised health systems and/or high levels of independence across its decision-making authorities. We call for a single database containing all recipient types, full location details and published with associated descriptive and network statistics.

Project description:BackgroundThe Japanese Society of Respiratory Care Medicine and the Japanese Society of Intensive Care Medicine provide here a clinical practice guideline for the management of adult patients with ARDS in the ICU.MethodThe guideline was developed applying the GRADE system for performing robust systematic reviews with plausible recommendations. The guideline consists of 13 clinical questions mainly regarding ventilator settings and drug therapies (the last question includes 11 medications that are not approved for clinical use in Japan).ResultsThe recommendations for adult patients with ARDS include: we suggest against early tracheostomy (GRADE 2C), we suggest using NPPV for early respiratory management (GRADE 2C), we recommend the use of low tidal volumes at 6-8 mL/kg (GRADE 1B), we suggest setting the plateau pressure at 30cmH20 or less (GRADE2B), we suggest using PEEP within the range of plateau pressures less than or equal to 30cmH2O, without compromising hemodynamics (Grade 2B), and using higher PEEP levels in patients with moderate to severe ARDS (Grade 2B), we suggest using protocolized methods for liberation from mechanical ventilation (Grade 2D), we suggest prone positioning especially in patients with moderate to severe respiratory dysfunction (GRADE 2C), we suggest against the use of high frequency oscillation (GRADE 2C), we suggest the use of neuromuscular blocking agents in patients requiring mechanical ventilation under certain circumstances (GRADE 2B), we suggest fluid restriction in the management of ARDS (GRADE 2A), we do not suggest the use of neutrophil elastase inhibitors (GRADE 2D), we suggest the administration of steroids, equivalent to methylprednisolone 1-2mg/kg/ day (GRADE 2A), and we do not recommend other medications for the treatment of adult patients with ARDS (GRADE1B; inhaled/intravenous β2 stimulants, prostaglandin E1, activated protein C, ketoconazole, and lisofylline, GRADE 1C; inhaled nitric oxide, GRADE 1D; surfactant, GRADE 2B; granulocyte macrophage colony-stimulating factor, N-acetylcysteine, GRADE 2C; Statin.).ConclusionsThis article was translated from the Japanese version originally published as the ARDS clinical practice guidelines 2016 by the committee of ARDS clinical practice guideline (Tokyo, 2016, 293p, available from http://www.jsicm.org/ARDSGL/ARDSGL2016.pdf). The original article, written for Japanese healthcare providers, provides points of view that are different from those in other countries.

Dataset Information

Pharmaceutical company payments to dermatology Clinical Practice Guideline authors in Japan.

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Pharmaceutical company payments to dermatology Clinical Practice Guideline authors in Japan.

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