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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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In the citing paper
“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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“showed that drug trials financed by pharmaceutical companies are less likely to be published, but that those published more frequently yield positive results for the sponsors’ products than do independently funded studies (8).”
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“Our findings add to the existing evidence that single-source sponsorship is associated with outcomes that favor the sponsors’ products (Bekelman et al. 2003; Davidson 1986; Lexchin et al. 2003; Stelfox et al. 1998).”
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“Financial con-flict of interest, a demonstrated source of publication bias in pharmaceutical studies (Friedman & Richter, 2004; Lexchin et al., 2003; Perlis et al., 2005), may also be considered in rating risk of bias (Bero, 2013; Roseman et al., 2011, 2012), although conflict of interest may be…”
BackgroundIndustry sponsorship and selection of comparators in randomized clinical trials
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“…and covert influence of the vested interests of study sponsors on results (sponsorship bias) has recently received a fair amount of attention (Healy, 2006 ; Heres et al., 2006 ; Lexchin et al., 2003 ; Lexchin and Light, 2006 ; Montgomery et al., 2004a; Perlis et al., 2005 ; Procyshyn et al., 2004).”
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“It is known that published studies sponsored by the pharmaceutical industry are more likely to have outcomes favouring the sponsor than studies that have other sponsors.(154,155) As the evidence relates to published studies, we do not know whether or not the findings are applicable to CSRs.”
ResultDiabetes and schizophrenia 2005: are we any closer to understanding the link?
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“This phenomena has been observed for a variety of treatments (Lexchin et al., 2003), leading to pressure on companies to make their data more freely available through, for example, clinical trial registries available online.”
BackgroundA Social Media Study on the Effects of Psychiatric Medication Use
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“In addition, these clinical trials suffer from limitations such as non-standardized study design, confounding factors, and restrictive eligibility criteria (Lexchin et al. 2003).”
BackgroundDisease Prevention and Health Promotion
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“CAM-oriented practitioners may be just as apt to discourage the use of standard preventive interventions of conventional medicine, citing its reliance on pharmaceuticals and invasive procedures, a failure to respect nature, a systemic lack of compassion and patient centeredness, and financial conflicts of interest.(14…”
BackgroundTreatment of ankylosing spondylitis with TNF blockers: a meta-analysis
Machado, M. A. D. Á., Barbosa, M. M., Almeida, A. M., de Araújo, V. E., Kakehasi, A. M., Andrade, E. I. G., Cherchiglia, M. L., & Acúrcio, F. D. A. (2013) · Rheumatology International · doi:10.1007/s00296-013-2772-6 · Cited by 95
“Systematic reviews have shown that studies connected to the pharmaceutical industry tend to report outcomes favorable to the medication produced by the sponsor [60–62].”
BackgroundRooney, A. A., Cooper, G. S., Jahnke, G. D., Lam, J., Morgan, R. L., Boyles, A. L., Ratcliffe, J. M., Kraft, A. D., Schünemann, H. J., Schwingl, P. J., et al. (2016) · Environment International · doi:10.1016/j.envint.2016.01.005 · Cited by 95
“…ability of funding source to influence study outcome, from studies on health impacts of tobacco (Barnes and Bero, 1997, 1998), to safety and efficacy of pharmaceuticals (Bero et al., 2007; Lexchin et al., 2003; Lundh et al., 2012; Perlis et al., 2005), and medical procedures (Popelut et al., 2010).”
Searching for unpublished trials in Cochrane reviews may not be worth the effort
van Driel, M., Sutter, A. D., Maeseneer, J. D., & Christiaens, T. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2008.09.010 · Cited by 94
Watanabe, N., Omori, I. M., Nakagawa, A., Cipriani, A., Barbui, C., McGuire, H., Churchill, R. C., & Furukawa, T. A. (2009) · CNS Drugs · doi:10.2165/11319480-000000000-00000 · Cited by 95
Fretheim, A., Odgaard‐Jensen, J., Brørs, O., Madsen, S., Njølstad, I., Norheim, O. F., Svilaas, A., Kristiansen, I. S., Thürmer, H. L., & Flottorp, S. A. (2012) · BMC Medicine · doi:10.1186/1741-7015-10-33 · Cited by 95
“Such sponsorship has been associated with bias in favour of the product made by the funding company [65].”
BackgroundUse of nonhuman primates in research in North America.
Lankau, E. W., Turner, P. V., Mullan, R. J., & Galland, G. G. (2014) · PubMed Central · Cited by 94
Taking Financial Relationships into Account When Assessing Research
Resnik, D. B., & Elliott, K. C. (2013) · Accountability in Research · doi:10.1080/08989621.2013.788383 · Cited by 94
“A systematic review of 30 studies examining the relationship between pharmaceutical industry sponsorship and research outcomes found that studies with industry funding were more likely to report results that favored the company’s products than studies with independent sources of funding (Lexchin et al., 2003).”
BackgroundDeGroot, H., Uzunishvili, S., Weir, R., Al-Omari, A., & GOMES, B. K. L. (2012) · Journal of Bone and Joint Surgery · doi:10.2106/jbjs.j.01763 · Cited by 93
Tricco, A. C., Tetzlaff, J., Pham, B., Brehaut, J., & Moher, D. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2008.08.008 · Cited by 91
A systematic appraisal of allegiance effect in randomized controlled trials of psychotherapy
Dragioti, E., Dimoliatis, I., Fountoulakis, K. N., & Evangelou, E. (2015) · Annals of General Psychiatry · doi:10.1186/s12991-015-0063-1 · Cited by 91
Holzinger, F., & Chenot, J. (2010) · Evidence-based Complementary and Alternative Medicine · doi:10.1155/2011/382789 · Cited by 91
“Studies sponsored by the manufacturer are prone to publication bias [37].”
BackgroundMeta-analysis: Methods, strengths, weaknesses, and political uses
Noble, J. H. (2006) · Journal of Laboratory and Clinical Medicine · doi:10.1016/j.lab.2005.08.006 · Cited by 94
Antidepressants for the negative symptoms of schizophrenia
Rummel‐Kluge, C., Kissling, W., & Leucht, S. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005581.pub2 · Cited by 89
Etter, J., Burri, M., & Stapleton, J. (2007) · Addiction · doi:10.1111/j.1360-0443.2007.01822.x · Cited by 86
Miners, A. H., Garau, M., Fidan, D., & Fischer, A. J. (2004) · BMJ · doi:10.1136/bmj.38285.482350.82 · Cited by 89
Neonicotinoid Seed Treatments: Limitations and Compatibility with Integrated Pest Management
Tooker, J. F., Douglas, M. R., & Krupke, C. H. (2017) · Agricultural & Environmental Letters · doi:10.2134/ael2017.08.0026 · Cited by 92
“Page 1 of 5 Ample evidence from a variety of disciplines has demonstrated that industry funding can influence research conclusions in favor of spon-soring companies (Lexchin et al., 2003; Lesser et al., 2007; Lundh et al., 2017).”
BackgroundBradley, S. H., DeVito, N., Lloyd, K. E., Richards, G. C., Rombey, T., Wayant, C., & Gill, P. J. (2020) · Journal of the Royal Society of Medicine · doi:10.1177/0141076820956799 · Cited by 98
“The problem appears to be culturally entrenched and, in some cases, conflicts of interest are implicated.(7,27) Some journals have instituted initiatives to encourage publication of ‘negative’ findings to help remedy publication bias.”
BackgroundExenatide efficacy and safety: a systematic review
Norris, S. L., Lee, N., Thakurta, S., & Chan, B. K. S. (2009) · Diabetic Medicine · doi:10.1111/j.1464-5491.2009.02790.x · Cited by 90
Biehl, J. G. (2006) · Duke University Press eBooks · doi:10.1215/9780822387916-008 · Cited by 94
Diels, J., Cunha, M., Manaia, C., Sabugosa-Madeira, B., & Silva, M. (2011) · Food Policy · doi:10.1016/j.foodpol.2010.11.016 · Cited by 83
“Over time, associations have repeatedly been observed between study outcomes favoring the industry’s point of view and industry sponsorship, suggesting a publication bias generated through the presence of COIs (Ahmer et al., 2005; Als-Nielsen, 2003; Bekelman et al., 2003; Bhandari et al., 2004; Kjaergard and Als-Niels…”
BackgroundJagsi, R., Sheets, N. C., Jankovic, A., Motomura, A. R., Amarnath, S. R., & Ubel, P. A. (2009) · Cancer · doi:10.1002/cncr.24315 · Cited by 85
Effectiveness of second generation antipsychotics: A systematic review of randomized trials
Johnsen, E., & Jørgensen, H. A. (2008) · BMC Psychiatry · doi:10.1186/1471-244x-8-31 · Cited by 83
“flict of interest in research has become a major concern as a high number of psychotropic drug trials are financially supported by the industry, and "funding bias" has been pin-pointed by several authors [44-49].”
Manchikanti, L. (2014) · Pain Physician · doi:10.36076/ppj.2014/17/e263 · Cited by 84
Finfer, S. R., Ranieri, V. M., Thompson, B., Barie, P. S., Dhainaut, J.-F., Douglas, I. S., Gårdlund, B., Marshall, J. C., & Rhodes, A. (2008) · Intensive Care Medicine · doi:10.1007/s00134-008-1266-6 · Cited by 84
“As industry sponsored trials tend to report more favourable results than independent research [36, 37], and as some clinicians will be concerned by allegations that Lilly funded the Surviving Sepsis Campaign and used it to market DAA [38, 39], the most credible trial for all concerned would not be funded or conducted…”
Vries, R. G. D., & Lemmens, T. (2005) · Social Science & Medicine · doi:10.1016/j.socscimed.2005.11.026 · Cited by 85
“Studies also suggest that a sponsor’s drug is sometimes compared to an inappropriate dosage of a competitive drug, thus skewing the results in favor of the sponsor’s drug, by making the comparator look less efficient or more toxic (Lexchin et al., 2003).”
BackgroundThe Financing of Drug Trials by Pharmaceutical Companies and Its Consequences
Schott, G., Pachl, H., Limbach, U., Gundert‐Remy, U., Lieb, K., & Ludwig, W.-D. (2010) · Deutsches Ärzteblatt international · doi:10.3238/arztebl.2010.0295 · Cited by 85
Methods for Developing Evidence Reviews in Short Periods of Time: A Scoping Review
Abou-Setta, A. M., Jeyaraman, M. M., Attia, A. M., Al-Inany, H. G., Ferri, M., Ansari, M. T., Garritty, C., Bond, K., & Norris, S. L. (2016) · PLoS ONE · doi:10.1371/journal.pone.0165903 · Cited by 85
Antibiotics for acute maxillary sinusitis in adults
Ahovuo-Saloranta, A., Rautakorpi, U.-M., Borisenko, O., Liira, H., Williams, J. W., & Mākelä, M. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000243.pub3 · Cited by 92
RetractedCreating and using real-world evidence to answer questions about clinical effectiveness
de Lusignan, S., Crawford, L., & Munro, N. M. (2015) · Journal of Innovation in Health Informatics · doi:10.14236/jhi.v22i3.177 · Cited by 82
Action to protect the independence and integrity of global health research
Storeng, K. T., Abímbọ́lá, Ṣ., Balabanova, D., McCoy, D., Ridde, V., Filippi, V., Roalkvam, S., Akello, G., Parker, M., & Palmer, J. J. (2019) · BMJ Global Health · doi:10.1136/bmjgh-2019-001746 · Cited by 82
Guerrero, A. (2024) · doi:10.1093/oso/9780198856368.001.0001 · Cited by 86
Improving the use of research evidence in guideline development: 4. Managing conflicts of interests
Boyd, E. A., & Bero, L. A. (2006) · Health Research Policy and Systems · doi:10.1186/1478-4505-4-16 · Cited by 82
Self-citationGuidelines for randomized clinical trial protocol content: a systematic review
Tetzlaff, J., Chan, A., Kitchen, J., Sampson, M., Tricco, A. C., & Moher, D. (2012) · Systematic Reviews · doi:10.1186/2046-4053-1-43 · Cited by 89
“guideline [81], despite being required by the Declaration of Helsinki [87] and despite research showing that trials with financial competing interests report positive results more often than other trials [6,88,89].”
BackgroundResultO'Connor, A. M. C., Sargeant, J. M., Dohoo, I. R., Erb, H. N., Cevallos, M., Egger, M., Ersbøll, A. K., Martin, S. W., Nielsen, L. R., Pearl, D. L., et al. (2016) · Journal of Veterinary Internal Medicine · doi:10.1111/jvim.14592 · Cited by 93
“In human health, several investigations show strong associations between the source of funding and the conclusions of research articles (Davidson, 1986; Stelfox et al., 1998; Bekelman et al., 2003; Lexchin et al., 2003).”
Background
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
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