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      Financial conflicts of interest of clinicians making submissions to the pan-Canadian Oncology Drug Review: a descriptive study

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          Abstract

          Objectives

          This study examines financial conflict of interest (FCOI) of clinicians who made submissions to the pan-Canadian Oncology Drug Review (pCODR), the arm of the Canadian Agency for Drugs and Technology in Health that recommends whether oncology drug indications should be publicly funded. Final reports from pCODR published between October 2016 and February 2019 were examined.

          Design

          Descriptive study.

          Data sources

          Website of pCODR.

          Interventions

          None.

          Primary and secondary outcomes

          The primary outcome is the number of submissions declaring FCOI. Secondary outcomes are the number of times where clinicians agreed and disagreed with preliminary recommendation from pCODR and the association between the distribution of individual clinicians’ FCOI and pCODR’s funding recommendations.

          Results

          There were 46 drug indication reports from pCODR. Clinicians made 261 submissions. Clinicians declared they received payments from companies 323 times and named 38 different companies making those payments a total of 500 times. Financial conflicts with drug companies were declared in 176 (66.3%) of all submissions. In 21 (45.7%) of the 46 drug indications, 50% or more of the clinicians had a conflict with the company making the drug. Clinicians commented on 37 preliminary recommendations. In all 25 where pCODR recommended funding or conditional funding, the clinicians either agreed or agreed in part. pCODR recommended that the drug indication not be funded 12 times and 9 times clinicians disagreed with that recommendation. The distribution of clinician responses was statistically significantly different depending on whether pCODR recommended funding/conditional funding or do not fund p<0.0001 (Fisher exact test). The distribution of clinicians’ FCOI differed depending on whether the recommendation was fund/conditional fund or do not fund p=0.027 (Fisher exact test).

          Conclusion

          Financial conflicts with pharmaceutical companies are widespread among experts making submissions to the pCODR.

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          Most cited references13

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          The impact of disclosing financial ties in research and clinical care: a systematic review.

          Emma Barber, Luna S. Joffe, Catharina C. Gross … (2010)
          Despite increased demand for disclosure of physician and researcher financial ties (FTs) to industry, little is known about patients', research participants', or journal readers' attitudes toward FTs. We systematically reviewed original, quantitative studies of patients', research participants', or journal readers' views about FTs to pharmaceutical and medical device companies. The MEDLINE, Scopus, and Web of Knowledge databases were searched for English-language studies containing original, quantitative data on attitudes toward FTs. We screened 6561 citations and retrieved 244 potentially eligible abstracts. Of these, 20 met inclusion criteria. Eleven studies assessed FTs and perceptions of quality. In clinical care, patients believed FTs decreased the quality and increased the cost of care. In research, FTs affected perceptions of study quality. In 2 studies, readers' perceptions of journal article quality decreased after disclosure of FTs. Eight studies assessed the acceptability of FTs. Patients were more likely to view personal gifts to physicians as unacceptable, compared with professional gifts. In 6 of the 10 studies that assessed the importance of disclosure, most patients and research participants believed FTs should be disclosed; in the other 4, approximately one-quarter believed FTs should be disclosed. Among the 7 studies assessing willingness to participate in research, approximately one-quarter of participants reported less willingness after disclosure of FTs. Patients believe that FTs influence professional behavior and should be disclosed. Patients, physicians, and research participants believe FTs decrease the quality of research evidence, and, for some, knowledge of FTs would affect willingness to participate in research.
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            Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings.

            Rachel R. Stine, Francisca C. Almeida, Lisa Wolfe … (2006)
            In January 2002, the US Food and Drug Administration (FDA) issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings. To characterize financial conflict disclosures at drug-related meetings, and to assess the relationship between conflicts and voting behavior at meetings that considered specific products. Cross-sectional study using agendas and transcripts from all FDA Drug Advisory Committee meetings (2001-2004) listed on the FDA Web site. Conflict rates, type, and size. The relationship between having a conflict and voting in favor of the index drug was described for each voter using Mantel-Haenszel relative risks and Monte Carlo simulations; Spearman rho was used for a meeting-level analysis comparing rates of conflict with voting patterns. The impact of the removal of persons with conflicts of interest on the vote margins was also evaluated. A total of 221 meetings held by 16 advisory committees were included in the study. In 73% of the meetings, at least 1 advisory committee member or voting consultant disclosed a conflict; only 1% of advisory committee members were recused. For advisory committee members (n = 1957) and voting consultants combined (n = 990), 28% (n = 825) disclosed a conflict. The most commonly specified conflicts were consulting arrangements, contracts/grants, and investments. Nineteen percent of consulting arrangements involved over 10,000 dollars, 23% of contracts/grants exceeded 100,000 dollars, and 30% of investments were over 25,000 dollars. The meeting-level analysis did not show a statistically significant relationship between conflict rates ("index conflict," "competitor conflict," or "any conflict") and voting patterns, but a weak, statistically significant positive relationship was apparent for competitor conflict and any conflict in the Mantel-Haenszel analyses. The Monte Carlo analyses produced similar findings in the competitor conflict analysis only. In all 3 conflict categories, the exclusion of advisory committee members and voting consultants with conflicts would have produced margins less favorable to the index drug in the majority of meetings, but this would not have changed whether the majority favored or opposed the drug. Disclosures of conflicts of interest at drug advisory committee meetings are common, often of considerable monetary value, and rarely result in recusal of advisory committee members. A weak relationship between certain types of conflicts and voting behaviors was detected, but excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.
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              Patients' views on financial conflicts of interest in cancer research trials.

              Ezekiel J. Emanuel, Steven Joffe, Steven Gross … (2006)
              Financial ties between researchers or medical centers and companies whose drugs are being tested have come under increasing scrutiny. We conducted in-person interviews with 253 patients in cancer-research trials (a 93% response rate) at five U.S. medical centers to determine their attitudes regarding potential financial conflicts of interest among researchers and medical centers. More than 90% of patients expressed little or no worry about financial ties that researchers or institutions might have with drug companies. Most patients said they would have enrolled in the trial even if the drug company had paid the researcher for speaking (82% of those interviewed) or consulting (75%) or if the researcher had received royalty payments (70%) or owned stock in the company (76%). Similarly, most patients would have enrolled in the trial if their cancer center had owned stock in the drug company (77%) or received royalty payments from the company (79%). Most patients believed it was ethical for researchers to receive speaking fees (81%) or consulting fees (82%) from the company. However, a substantial minority of patients wanted disclosure of the oversight system for researchers (40%) and of researchers' financial interests (31%); 17% thought no disclosure to patients was necessary. Most patients in cancer-research trials were not worried about financial ties between researchers or medical centers and drug companies and would still have enrolled in the trial if they had known about such financial ties. A substantial minority wanted to be informed about the oversight system to protect against financial conflicts of interest and about researchers' financial interests. Copyright 2006 Massachusetts Medical Society.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2019
                Publication date (Electronic): 26 July 2019
                Volume: 9
                Issue: 7
                Electronic Location Identifier: e030750
                Affiliations
                [1] School of Health Policy & Management, York University , Toronto, Ontario, Canada
                Author notes
                [Correspondence to ] Dr Joel Lexchin; jlexchin@ 123456yorku.ca
                Author information
                http://orcid.org/0000-0001-5120-8029
                Article
                Publisher ID: bmjopen-2019-030750
                DOI: 10.1136/bmjopen-2019-030750
                PMC ID: 6661552
                PubMed ID: 31350254
                SO-VID: c06bff92-64a6-4a2c-94f0-bae685eb3b4a
                Copyright © © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 29 March 2019
                Date revision received : 02 June 2019
                Date accepted : 10 June 2019
                Categories
                Subject: Health Policy
                Subject: Research
                Subject: 1506
                Subject: 1703
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: financial conflict of interest,pan-canadian oncology drug review,clinician,medicines,funding recommendations
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: financial conflict of interest, pan-canadian oncology drug review, clinician, medicines, funding recommendations

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