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Pharmaceutical industry sponsorship and research outcome and quality: systematic review
Open accessAbstract
OBJECTIVE: To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. METHODS: Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. RESULTS: 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. CONCLUSION: Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
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“pharmaceutical companies, who fund a substantial number of RCTs, are more likely to seek publication of results with statistically positive outcomes. 9”
From Reporting research results: a moral obligation for all researchers. (2007) · cites this paper as [9]
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“Several investigations show strong associations between the source of funding and the conclusions of research articles [ 219 – 222 ].”
From Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration (2007) · cites this paper as [222]
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“Empirical evidence points toward funding source sometimes being associated with estimated treatment effects [30].”
From CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials (2010) · cites this paper as [30]
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“For example, bias, as indicated by a prevalence of more favourable outcomes, has been demonstrated for clinical research funded by industry compared with studies funded by other sources [257–259].”
From Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0 (2020) · cites this paper as [259]
In the citing paper
“Additionally, different outcomes from the same trials can be a source of pharmaceutical marketing bias.35”
In the citing paper
“Lexchin and colleagues [166] observed that outcomes of reports of randomized trials and meta-analyses of clinical trials funded by the pharmaceutical industry are more likely to favor the sponsor's product compared to studies with other sources of funding.”
From The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration (2009) · cites this paper as [166]
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Drug policy down under: Australia's pharmaceutical benefits scheme.
Duckett, S. J. (2004) · PubMed Central · Cited by 51
Ho, R. S., Wu, X., Yuan, J., Liu, S., Lai, X., Wong, S. Y., & Chung, V. C. (2015) · npj Primary Care Respiratory Medicine · doi:10.1038/npjpcrm.2014.102 · Cited by 50
Windsor, B., Popovich, I., Jordan, V., Showell, M., Shea, B., & Farquhar, C. (2012) · Human Reproduction · doi:10.1093/humrep/des342 · Cited by 46
“Research that is funded by pharmaceutical companies is more likely to publish favourable outcomes supporting the company (Lexchin et al., 2003).”
BackgroundResnik, D. B., Konecny, B., & Kissling, G. E. (2016) · Journal of Occupational and Environmental Medicine · doi:10.1097/jom.0000000000000910 · Cited by 56
Complementary Therapy Systems and Their Integrative Evaluation
Kienle, G. S., Albonico, H. U., Fischer, L., Frei-Erb, M., Hamre, H. J., Heusser, P., Matthiessen, P. F., Renfer, A., & Kiene, H. (2011) · EXPLORE · doi:10.1016/j.explore.2011.02.001 · Cited by 50
“Even in studies appearing to be methodologically perfect, results can still depend on imponderables such as the source of sponsoring.(57) RCTs on the same interventions often show substantial variation in results, as do corresponding systematic reviews and meta-analyses.”
BackgroundWu, M., Sirota, M., Butte, A., & Chen, B. (2014) · Pacific Symposium on Biocomputing · doi:10.1142/9789814644730_0008 · Cited by 55
“Another possible explanation is that industry and academia are increasingly linked, and conflicts of interest may exist [19-21].”
BackgroundModafinil for the treatment of attention-deficit/hyperactivity disorder: A meta-analysis
Wang, S., Han, C., Lee, S.-J., Jun, T., Patkar, A. A., Masand, P. S., & Pae, C. (2016) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2016.09.034 · Cited by 55
“(Bero, 2013; Lexchin et al., 2003; Lundh et al., 2012) In this perspective, there might have been by industry bias because pharmaceutical company owning Provigil (brand name of modafinil), Cephalon, was involved in 4/5 RCTs.”
BackgroundPoverty, Environment, and Health
O’Neill, M. S., McMichael, A. J., Schwartz, J. D., & Wartenberg, D. E. (2007) · Epidemiology · doi:10.1097/ede.0b013e3181570ab9 · Cited by 49
The medical profession and the pharmaceutical industry: when will we open our eyes?
Breen, K. J. (2004) · The Medical Journal of Australia · doi:10.5694/j.1326-5377.2004.tb05994.x · Cited by 50
The Role of the Pharmaceutical Industry in Teaching Psychopharmacology: A Growing Problem
Brodkey, A. C. (2005) · Academic Psychiatry · doi:10.1176/appi.ap.29.2.222 · Cited by 50
The Limits of Evidence-Based Medicine in Psychiatry
Thomas, P., Bracken, P. J., & Timimi, S. B. (2012) · Project Muse (Johns Hopkins University) · Cited by 48
de Lemos, L. L. P., Costa, J. D. O., Almeida, A. M., de Oliveira, H. A., Barbosa, M. M., Kakehasi, A. M., & Acúrcio, F. D. A. (2014) · Rheumatology International · doi:10.1007/s00296-014-3006-2 · Cited by 49
“SRs revealed that industry-funded studies tend to show results favorable to their product when compared to studies not funded by industry [68, 69].”
ResultPublication of Clinical Trials in Scientific Journals: Editorial Issves
Alfonso, F., Segovia, J., Heras, M., & Bermejo, J. (2006) · Revista Española de Cardiología (English Edition) · doi:10.1016/s1885-5857(07)60074-7 · Cited by 52
Barbosa, M. W. P., Valadares, N. P. B., Barbosa, A., Amaral, A., Iglesias, J. R., Nastri, C. O., Martins, W. P., & Nakagawa, H. M. (2018) · JBRA · doi:10.5935/1518-0557.20180018 · Cited by 49
“(2017) and the others included was the double-blinding procedure, which in fact minimizes the risk of bias (Lexchin et al., 2003).”
BackgroundWhen fragments link: a bibliometric perspective on the development of fragment-based drug discovery
Romasanta, A. K. S., van der Sijde, P., Hellsten, I., Hubbard, R. E., Keserű, G. M., van Muijlwijk‐Koezen, J. E., & de Esch, I. J. P. (2018) · Drug Discovery Today · doi:10.1016/j.drudis.2018.05.004 · Cited by 50
“Considering that the industry has the opposite incentive of withholding information for competitive advantage [28,29], it emphasizes how influential the industry was in the development of FBDD.”
BackgroundNew generation antipsychotics for first episode schizophrenia
Hamann, J., Kissling, W., Leucht, S., & Rummel‐Kluge, C. (2003) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004410 · Cited by 48
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene
Lemmens, T. (2004) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2004.tb01969.x · Cited by 51
The Role of Conflict of Interest in Reporting of Scientific Information
Irwin, R. S. (2009) · CHEST Journal · doi:10.1378/chest.09-0890 · Cited by 49
Assessing Confidence in the Results of Network Meta-Analysis (Cinema)Preprint
Nikolakopoulou, A., Higgins, J. P. T., Papakonstantinou, T., Chaimani, A., Giovane, C. D., Egger, M., & Salanti, G. (2019) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/597047 · Cited by 49
“expressed in a prediction interval, which shows where the true effect of a new study similar 347 to the existing studies is expected to lie (28).”
BackgroundShort and long term effects of tibolone in postmenopausal women
Formoso, G., Perrone, E., Maltoni, S., Balduzzi, S., D’Amico, R., Bassi, M. C., Basevi, V., Marata, A. M., Magrini, N., & Maestri, E. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008536.pub2 · Cited by 49
Ho, E. T. L., Wong, G., Craig, J. C., & Chapman, J. R. (2013) · Transplantation · doi:10.1097/tp.0b013e318284c15b · Cited by 48
“It has been demonstrated that systematic bias occurs, favoring the product of interests if the research is funded by the company who made the product (35).”
BackgroundPhysicians, Social Media, and Conflict of Interest
DeCamp, M. W. (2012) · Journal of General Internal Medicine · doi:10.1007/s11606-012-2251-x · Cited by 49
Evers, S., Hiligsmann, M., & Adarkwah, C. C. (2014) · Psychology and Health · doi:10.1080/08870446.2014.953532 · Cited by 53
“One of the explanations for this difference might be the lower methodological quality of studies submitted by the industry (Bell et al., 2006; Hill et al., 2000; Lexchin et al., 2003).”
BackgroundUnfractionated or low-molecular weight heparin for induction of remission in ulcerative colitis
Chande, N., McDonald, J. W., MacDonald, J. K., & Wang, J. J. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006774.pub3 · Cited by 48
Nicotine receptor partial agonists for smoking cessation
Cahill, K., Stead, L. F., & Lancaster, T. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103.pub4 · Cited by 46
Metadata
- Authors
- Lexchin, J., Bero, L. A., Djulbegovic, B., & Clark, O.
- Affiliations
- York University (CA)
- University of California, San Francisco (US)
- Corresponding author
- Lexchin, Joel
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2003-05-29
- Volume
- 326
- Issue
- 7400
- Pages
- 1167-1170
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC156458
- OpenAlex
- W2136284733
- Cited by
- 2,147
- References
- 81
- Citations by year
- 2026: 34 · 2025: 49 · 2024: 61 · 2023: 56 · 2022: 57 · 2021: 53 · 2020: 89 · 2019: 74 · 2018: 86 · 2017: 84 · 2016: 82 · 2015: 100 · 2014: 114 · 2013: 107 · 2012: 150
- FWCI
- 10.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Global Public Health Policies and Epidemiology
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- pharmaceutical industry sponsorship, research bias, publication bias, trial quality, research funding sources, comparator selection, conflicts of interest
- MeSH terms
- Clinical Trials as Topic, Drug Industry, Financing, Organized, Publishing, Research, Research Support as Topic
About these checks
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