Cited by 61Pharmaceutical industry and healthcareLipoproteins and Cardiovascular HealthStatistical Methods in Clinical Trials

Industry sponsorship bias in research findings: a network meta-analysis of LDL cholesterol reduction in randomised trials of statins

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Naci, H., Dias, S., Ades, A. E.·2014·BMJ

Abstract

OBJECTIVE: To explore the risk of industry sponsorship bias in a systematically identified set of placebo controlled and active comparator trials of statins. DESIGN: Systematic review and network meta-analysis. ELIGIBILITY: Open label and double blind randomised controlled trials comparing one statin with another at any dose or with control (placebo, diet, or usual care) for adults with, or at risk of developing, cardiovascular disease. Only trials that lasted longer than four weeks with more than 50 participants per trial arm were included. Two investigators assessed study eligibility. DATA SOURCES: Bibliographic databases and reference lists of relevant articles published between 1 January 1985 and 10 March 2013. DATA EXTRACTION: One investigator extracted data and another confirmed accuracy. MAIN OUTCOME MEASURE: Mean absolute change from baseline concentration of low density lipoprotein (LDL) cholesterol. DATA SYNTHESIS: Study level outcomes from randomised trials were combined using random effects network meta-analyses. RESULTS: We included 183 randomised controlled trials of statins, 103 of which were two-armed or multi-armed active comparator trials. When all of the existing randomised evidence was synthesised in network meta-analyses, there were clear differences in the LDL cholesterol lowering effects of individual statins at different doses. In general, higher doses resulted in higher reductions in baseline LDL cholesterol levels. Of a total of 146 industry sponsored trials, 64 were placebo controlled (43.8%). The corresponding number for the non-industry sponsored trials was 16 (43.2%). Of the 35 unique comparisons available in 37 non-industry sponsored trials, 31 were also available in industry sponsored trials. There were no systematic differences in magnitude between the LDL cholesterol lowering effects of individual statins observed in industry sponsored versus non-industry sponsored trials. In industry sponsored trials, the mean change from baseline LDL cholesterol level was on average 1.77 mg/dL (95% credible interval -11.12 to 7.66) lower than the change observed in non-industry sponsored trials. There was no detectable inconsistency in the evidence network. CONCLUSIONS: Our analysis shows that the findings obtained from industry sponsored statin trials seem similar in magnitude as those in non-industry sources. There are actual differences in the effectiveness of individual statins at various doses that explain previously observed discrepancies between industry and non-industry sponsored trials.

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  • The interference of industry bias is likely minimal, given the lack of profits available for CoQ10.

    “The interference of industry bias is likely minimal, in contrast to other subject areas [22,23], given the lack of profits available for CoQ10.”

    From Effect of Coenzyme Q10 on statin-associated myalgia and adherence to statin therapy: A systematic review and meta-analysis (2020) · cites this paper as [22]

    The Discussion (Generalisability of findings; page unavailable) describes publication practices that can favour industry-funded research, supporting the contrast with potential bias in other subject areas. The paper does not address CoQ10, its profitability, or whether industry bias is minimal in CoQ10 research; its own statin analysis found no evidence of sponsorship bias. (LLM, conf=0.86)

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Research works printed but not linked: 2

  1. [24]Naci H, Brugts J, Fleurence R, Ades AE. Comparative efficacy and safety of statins: a systematic review and mixed treatment comparison—final protocol. 2009. www2.lse.ac.uk/LSEHealthAndSocialCare/pdf/HNaciProtocol.pdf.
  2. [30]Dias S, Welton N, Sutton A, Ades A. NICE DSU technical support document 2: a generalized linear modelling framework for pairwise and network meta-analysis of randomized controlled trials. 2011. www.nicedsu.org.uk/TSD2%20General%20meta%20analysis%20corrected%2015April2014.pdf. 27466657

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Authors
Naci, H., Dias, S., & Ades, A. E.
Affiliations
  • Harvard University (US)
  • University of Bristol (GB)
Corresponding author
Naci, H.
Venue
BMJ
Publisher
BMJ
Published
2014-10-03
Volume
349
Issue
oct03 1
Pages
g5741-g5741
ISSN
1756-1833 (ISSN-L)
OpenAlex
W1975964712
Cited by
61
References
60
Citations by year
2024: 4 · 2023: 7 · 2022: 2 · 2021: 2 · 2020: 8 · 2019: 5 · 2018: 9 · 2017: 6 · 2016: 4 · 2015: 11 · 2014: 3
FWCI
1.43
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • BMJ (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Bristol Research (University of Bristol) (publishedVersion, cc-by-nc)
  • London School of Economics and Political Science Theses Online (London School of Economics and Political Science) (acceptedVersion, cc-by-nc)
  • Explore Bristol Research (submittedVersion, cc-by-nc)
  • Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
  • HighWire Press Open Archive (submittedVersion)
Funders
McMaster University
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
statins, LDL cholesterol lowering, pharmaceutical industry funding, research funding conflicts of interest, cardiovascular disease prevention
MeSH terms
Drug Industry, Humans, Cholesterol, LDL, Bias, Randomized Controlled Trials as Topic, Hydroxymethylglutaryl-CoA Reductase Inhibitors

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