Ten years later: a review of the US 2009 institute of medicine report on conflicts of interest and solutions for further reform

Torgerson, Trevor; Wayant, Cole; Cosgrove, Lisa; Akl, Elie A.; Checketts, Jake X.; Dal‐Ré, Rafael; Gill, Jennifer; Grover, Samir C.; Khan, Nasim A.; Khan, Rishad; Marušić, Ana; McCoy, Matthew S.; Mitchell, Aaron P.; Prasad, Vinay; Vassar, Matt

doi:10.1136/bmjebm-2020-111503

Cited by 25 publications

(16 citation statements)

References 120 publications

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“…Financial conflicts of interest (FCOIs) can bias healthcare research, practice, education and policy. [1][2][3] The last decade has seen a global trend towards addressing concerns about FCOIs by publishing drug company payments to the healthcare sector. [4][5][6][7][8] It is best exemplified by the US Sunshine Act establishing Open Payments, a database triggering extensive research on payment distribution, 9 10 and its links with drug prescription 11 and cost.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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.

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Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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“…Financial conflicts of interest (COIs) are a perennial problem for medical research and practice. 1,2 Physician researchers who receive industry payments are more likely to demonstrate results favorable to the companies funding them; 3,4 are more likely to prescribe drugs and use of medical devices produced by these companies, from statins 5 to opioids 6 to endoscopic 7 and orthopedic devices; 8 and they may unduly influence other physicians by contributing to research that others use to guide their own clinical practice. [9][10][11][12][13][14][15][16] Industry payments to physicians therefore may bias healthcare providers' delivery of evidence-based medicine and interfere with their responsibilities to their patients.…”

Section: Introductionmentioning

confidence: 99%

A Cross-Sectional Examination of Conflict-of-Interest Disclosures of Physician-Authors Publishing in High-Impact US Medical Journals

Baraldi

Picozzo

Arnold

et al. 2021

Preprint

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Objective: To assess the accuracy of self-reported financial conflict-of-interest (COI) disclosures in the New England Journal of Medicine (NEJM) and Journal of the American Medical Association (JAMA) within the requisite disclosure period prior to article submission. Design: Cross-sectional investigation. Data Sources: Original clinical-trial research articles published in NEJM (n = 206) or JAMA (n = 188) from January 1 to December 31, 2017; self-reported COI disclosure forms submitted to NEJM or JAMA with the authors published articles; Open Payments website (from database inception; latest search: August 2019). Main outcome measures: Financial data reported to Open Payments from 2014 to 2016 (time period that included all subjects requisite disclosure windows) were compared to self-reported disclosure forms submitted to the journals. Payments were defined as those not associated with a research study or formal research funding. Payment types were categorized as disclosed, undisclosed, indeterminate, or unrelated. Results: Thirty-one articles from NEJM and 31 articles from JAMA met inclusion criteria. The physician-authors (n = 118) received a combined total of $7.48 million. Of the 106 authors (89.8%) who received payments, 86 (81.1%) received undisclosed payments. The top 23 most highly compensated received $6.32 million, of which $3.00 million (47.6%) was undisclosed. Disclosure rates were the equivalent between the top 23 and the entire sample. Conclusions: High payment amounts, as well as high proportions of undisclosed financial compensation, regardless of amount received, comprised potential COIs for two influential US medical journals. Further research is needed to explain why such high proportions of general payments were undisclosed and whether journals that rely on self-reported COI disclosure need to reconsider their policies.

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“…We understand that the term “conflicts of interest” would likely be difficult to grasp by many participants in developing countries. This is likely, but less so in developed countries, in which other types of conflicts should be considered [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

How WHO Solidarity Plus trial participants in countries on four continents are informed in writing

2023

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Background It is unknown if changes have been made to the original participant’s information sheet/informed consent form (PIS/ICF) provided by the WHO Solidarity Plus team when it was transferred to participating countries. Methods National principal investigators from 30 countries were asked if the original PIS/ICF was edited in their countries and, if so, to share with us the one used to recruit participants. We assessed whether the 25 different elements of information from the good clinical practice guidelines and the Declaration of Helsinki were present in, deficiently described, or absent from the PIS/ICFs. Results Nineteen national principal investigators responded: eight (Argentina, Brazil, Ethiopia, Georgia, Iran, Lebanon, Lithuania, and Malaysia) stated that no edits were introduced to the original PIS/ICF; eight (Canada, Colombia, Philippines, India, Ireland, Pakistan, Portugal, and Switzerland) added some elements of information in the national PIS/ICF; and three (Italy, Peru, and Spain) reported not participating in the trial. None of the elements included in the original PIS/ICF were omitted from the edited PIS/IFC. Six elements of information were omitted and five deficiently described in the original PIS/ICF. The number of elements omitted from the edited PIS/ICFs varied (range = 2-5). Nine PIS/ICFs incompletely described or omitted the informing of study participants about the study results, while five deficiently described or omitted the anticipated expenses for trial participation. Information concerning whom to contact for more information or in case of injury was deficient in six PIS/ICFs. Unlike the original PIS/ICF, all edited PIS/ICFs informed participants about the existence of compensation or treatment for any injury related to the trial. Conclusions WHO should consider adding three of the omitted elements in PIS/ICFs of future multinational similar trials.

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Ten years later: a review of the US 2009 institute of medicine report on conflicts of interest and solutions for further reform

Cited by 25 publications

References 120 publications

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

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

A Cross-Sectional Examination of Conflict-of-Interest Disclosures of Physician-Authors Publishing in High-Impact US Medical Journals

How WHO Solidarity Plus trial participants in countries on four continents are informed in writing

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