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Research

Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1344 (Published 19 March 2010) Cite this as: BMJ 2010;340:c1344
  1. Amy T Wang, resident in internal medicine12,
  2. Christopher P McCoy, chief resident in internal medicine1,
  3. Mohammad Hassan Murad, assistant professor of medicine123,
  4. Victor M Montori, professor of medicine124
  1. 1Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA
  2. 2Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN, USA
  3. 3Division of Preventive, Occupational and Aerospace Medicine, Mayo Clinic, Rochester, MN, USA
  4. 4Division of Endocrinology, Mayo Clinic, Rochester, MN, USA
  1. Correspondence to: M H Murad murad.mohammad{at}mayo.edu
  • Accepted 21 December 2009

Abstract

Objective To explore a possible link between authors’ financial conflicts of interest and their position on the association of rosiglitazone with increased risk of myocardial infarction in patients with diabetes.

Data sources On 10 April 2009, we searched Web of Science and Scopus for articles citing and commenting on either of two index publications that contributed key data to the controversy (a meta-analysis of small trials and a subsequent large trial).

Data selection Articles had to comment on rosiglitazone and the risk of myocardial infarction. Guidelines, meta-analyses, reviews, clinical trials, letters, commentaries, and editorials were included.

Data extraction For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.

Results Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view (rate ratio 3.38, 95% CI 2.26 to 5.06 and 4.29, 2.63 to 7.02, respectively). There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest (3.36, 1.94 to 5.83). These links persisted when articles rather than authors were used as the unit of analysis (4.69, 2.84 to 7.72), when the analysis was restricted to opinion articles (6.29, 2.15 to 18.38) or to articles in which the rosiglitazone controversy was the main focus (6.50, 2.56 to 16.53), and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone (3.43, 0.99 to 11.82 and 4.95, 2.87 to 8.53, respectively).

Conclusions Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.

Footnotes

  • Contributors: ATW, MHM, and VMM conceived and designed the study. ATW and CPM reviewed articles and extracted data. ATW and MHM analysed the data. ATW, MHM, and VMM wrote the paper. All authors had full access to the data in the study, can take responsibility for the integrity of the data and the accuracy of the data analysis, and edited and approved the final version. VMM is the guarantor.

  • Funding: No funding was required for this study.

  • Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) No financial support for the submitted work from anyone other than their employer; (2) No financial relationships with commercial entities that might have an interest in the submitted work; (3) No spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; (4) No non-financial interests that may be relevant to the submitted work.

  • Ethical approval: Not required.

  • Data sharing: All data is in the web extra file. No additional data is available.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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