Conflicts of Interest Among Infectious Diseases Clinical Practice Guideline Authors and the Pharmaceutical Industry.
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ABSTRACT:
SUBMITTER: Ahiskali AS
PROVIDER: S-EPMC10111177 | biostudies-literature | 2023 Apr
REPOSITORIES: biostudies-literature
Publications
Conflicts of Interest Among Infectious Diseases Clinical Practice Guideline Authors and the Pharmaceutical Industry.
Ahiskali Aileen S AS Drekonja Dimitri M DM Alpern Jonathan D JD
JAMA network open 20230403 4
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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.
| S-EPMC6487566 | biostudies-literature
Project description: Not available
| S-EPMC11261266 | biostudies-literature
Project description: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.
| S-EPMC7553305 | biostudies-literature
Project description:Background and objectivesRigorous and transparent management strategies for conflicts of interest and clinical practice guidelines with the best available evidence are necessary for the development of nephrology guidelines. However, there was no study assessing financial and nonfinancial conflicts of interest, quality of evidence underlying the Japanese guidelines for CKD, and conflict of interest policies for guideline development.Design, setting, participants, & measurementsThis cross-sectional study examined financial and nonfinancial conflicts of interest among all 142 authors of CKD guidelines issued by the Japanese Society of Nephrology using a personal payment database from all 92 major Japanese pharmaceutical companies between 2016 and 2019 and self-citations by guideline authors. Also, the quality of evidence and strength of recommendations underlying the guidelines and conflicts of interest policies of Japanese, US, and European nephrology societies were evaluated.ResultsAmong 142 authors, 125 authors (88%) received $6,742,889 in personal payments from 56 pharmaceutical companies between 2016 and 2019. Four-year combined median payment per author was $8258 (interquartile range, $2230‒$51,617). The amounts of payments and proportion of guideline authors with payments remained stable during and after guideline development. The chairperson, vice chairperson, and group leaders received higher personal payments than other guideline authors. Of 861 references in the guidelines, 69 (8%) references were self-cited by the guideline authors, and 76% of the recommendations were on the basis of low or very low quality of evidence. There were no fully rigorous and transparent conflicts of interest policies for nephrology guideline authors in the United States, Europe, and Japan.ConclusionsMost of the Japanese CKD guideline recommendations were on the basis of low quality of evidence by the guideline authors tied with pharmaceutical companies, suggesting the need for better financial conflicts of interest management.
| S-EPMC9269663 | biostudies-literature
Project description:BackgroundConflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs).ObjectivesTo examine rates of disclosure of COI, including financial interests in companies that manufacture drugs that are recommended in CPGs on glycemic control in type 2 diabetes mellitus, and to explore the relationship between recommendations for specific drugs in a guideline and author COI.MethodsWe identified a cohort of relevant guidelines from the National Guideline Clearinghouse (NGC) and abstracted COI disclosures from all guideline authors for this observational, cross-sectional study. We determined which hypoglycemic drugs were recommended in each guideline, and explored the relationship between specific disclosures and whether a drug was recommended.ResultsAmong 13 included guidelines, the percentage of authors with one or more financial disclosures varied from 0 to 94% (mean 44.2%), and was particularly high for two US-based guidelines (91% and 94%). Three guidelines disclosed no author financial COI. The percentage of authors with disclosures of financial interests in manufacturers of recommended drugs was also high (mean 30%). On average, 56% of manufacturers of patented drugs recommended in each guideline had one or more authors with a financial interest in their company. We did not find a significant relationship between financial interests and whether a drug was recommended in our sample; US-based guidelines were more likely to make recommendations for a specific drug compared to non-US based guidelines.DiscussionAuthors of this cohort of guidelines have financial interests directly related to the drugs that they are recommending. Although we did not find an association between author COI and drugs recommended in these guidelines and we cannot draw conclusions about the validity of the recommendations, the credibility of many of these guidelines is in doubt.
| S-EPMC3796568 | biostudies-literature
Project description:ObjectiveTo evaluate the prevalence and accuracy of industry-related financial conflict of interest (COI) disclosures among US physician guideline authors.DesignCross-sectional study.SettingClinical practice guidelines published by the Council of Medical Specialty Societies in 2020.ParticipantsUS physician guideline authors.Main outcome measuresFinancial COI disclosures, both self-reported and determined using Open Payments data.ResultsAmong 270 US physician authors of 20 clinical practice guidelines, 101 (37.4%) disclosed industry-related financial COIs, whereas 199 (73.7%) were found to have received payments from industry when accounting for payments disclosed through Open Payments. The median payments received by authors during the 3-year period was US$27 451 (IQR, US$1385-US$254 677). Comparing authors' self-disclosures with Open Payments, 72 (26.7%) of the authors accurately disclosed their financial COIs, including 68 (25.2%) accurately disclosing no financial COIs and 4 (1.5%) accurately disclosing a financial COI. In contrast, 101 (37.4%) disclosed no financial COIs and were found to have received payments from industry, 23 (8.5%) disclosed a financial COI but had under-reported payments received from industry, 14 (5.2%) disclosed a financial COI but had over-reported payments received from industry and 60 (22.2%) disclosed a financial COI but were found to have both under-reported and over-reported payments received from industry. We found that inaccurate COI disclosure was more frequent among professors compared with non-professors (81.9% vs 63.5%; p<0.001) and among males compared with females (77.7% vs 64.8%; p=0.02). The accuracy of disclosures also varied among medical professional societies (p<0.001).ConclusionsFinancial relationships with industry are common among US physician authors of clinical practice guidelines and are often not accurately disclosed. To ensure high-quality guidelines and unbiased recommendations, more effort is needed to minimise existing COIs and improve disclosure accuracy among panel members.
| S-EPMC9872463 | biostudies-literature
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.
| S-EPMC5817443 | biostudies-other
Project description: Not available
| S-EPMC1336787 | biostudies-literature
Project description: Not available
| S-EPMC8610564 | biostudies-literature
Project description:BackgroundIntellectual conflicts of interest (COI), like financial COI, may threaten the validity and trustworthiness of clinical practice guidelines (CPGs). However, comparatively little is known about intellectual COI in CPGs. This study sought to estimate the prevalence of intellectual COI and corresponding management strategies among cardiology and pulmonology CPGs.MethodsWe conducted a retrospective document review of CPGs published by cardiology or pulmonology professional societies from the United States, Canada, or Europe from 2018 to 2019 available via the Emergency Care Research Institute, Guidelines International Network, or Medscape databases. We assessed the percentage of authors with an intellectual COI, defined as i) authorship on a study reviewed by the CPG, ii) authorship of a prior editorial related to a CPG recommendation, or iii) authorship of a prior related CPG. Management strategies assessed included use of GRADE methodology, inclusion of a methodologist, and recusals due to intellectual COI. Outcomes were assessed overall and compared between cardiology and pulmonology CPGs.ResultsAmong the 39 CPGs identified (14 cardiology, 25 pulmonology), there were a total of 737 authors, of whom 473 (64%) had at least one intellectual COI. Among all CPGs, a median of 67% (Interquartile Range 50%-76%) of authors had at least one intellectual COI, and COI was more prevalent among cardiology compared with pulmonology CPGs (84% vs 57%, p<0.001). There was variable use of management strategies among the CPGs, including use of GRADE methodology (64% of CPGs), inclusion of a methodologist (49%), and recusals due to intellectual COI (0%).ConclusionIntellectual conflicts of interest appear to be highly prevalent and under-reported among cardiology and pulmonology CPGs, which may threaten their validity. Greater attention to and improved management of intellectual COI by CPG-producing organizations is needed.
| S-EPMC10332620 | biostudies-literature