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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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“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
“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]
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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Tahhan, A. S., Vaduganathan, M., Kelkar, A. A., Georgiopoulou, V. V., Kalogeropoulos, A. P., Greene, S. J., Fonarow, G. C., Gheorghiade, M., & Butler, J. (2015) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2015.06.014 · Cited by 26
History, context, process, and rationale for the development of clinical guidelines.
Pilling, S. (2008) · Psychology and psychotherapy · doi:10.1348/147608308x324923 · Cited by 32
GRADE Leitlinien: 5. Einschätzung der Qualität der Evidenz – Publikationsbias
Nolting, A., Perleth, M., Langer, G., Meerpohl, J. J., Gartlehner, G., Kaminski-Hartenthaler, A., & Schünemann, H. J. (2012) · Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen · doi:10.1016/j.zefq.2012.10.015 · Cited by 25
Most meta-analyses of drug interventions have narrow scopes and many focus on specific agents
Haidich, A., Pilalas, D., Contopoulos‐Ioannidis, D. G., & Ioannidis, J. P. A. (2013) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2012.10.014 · Cited by 25
“Industry-funded trials are more likely to favor the experimental intervention in their results and conclusions [38], and this seems to occur through selection of suitable comparators [39e41].”
BackgroundSierles, F. S., Kessler, K., Mintz, M. L., Beck, G. L., Starr, S. R., Lynn, D. J., Chao, J., Cleary, L., Shore, W. B., Stengel, T. L., et al. (2015) · Academic Medicine · doi:10.1097/acm.0000000000000686 · Cited by 25
Ma, B., Qi, G.-Q., Lin, X., Wang, T., Chen, Z., & Yang, K. (2012) · The Journal of Alternative and Complementary Medicine · doi:10.1089/acm.2011.0274 · Cited by 24
“15 It was also disappointing that most reviews did not specify and present results of any assessment of risk of bias that may affect the cumulative evidence despite the fact that many studies had shown that assessment of the heterogeneity of risk of bias across studies was an essential part of…”
Factors Associated with Results and Conclusions of Trials of Thiazolidinediones
Rattinger, G. B., & Bero, L. A. (2009) · PLoS ONE · doi:10.1371/journal.pone.0005826 · Cited by 24
“We extracted data on the following publication characteristics shown to be independently related to favorable results or conclusions of some drug studies [2,5,7,10,25,26].”
MethodSelf-citationFrequentist versus Bayesian Clinical Trials
Teira, D. (2011) · Elsevier eBooks · doi:10.1016/b978-0-444-51787-6.50010-6 · Cited by 24
Contract research organizations in oncology clinical research: Challenges and opportunities
Roberts, D. A., Kantarjian, H. M., & Steensma, D. P. (2016) · Cancer · doi:10.1002/cncr.29994 · Cited by 24
Al‐Badriyeh, D., Alameri, M., & Al‐Okka, R. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-012648 · Cited by 25
“It is important to note here, however, that the Lexchin et al and Buchkowsky and Jewesson studies were simply focusing on the clinical trials research and up to the year 2000 only.”
ResultScott, J., Howard, B., Sinnett, P., Schiesel, M., Baker, J., Henderson, P. J., & Vassar, M. B. (2017) · The American Journal of Emergency Medicine · doi:10.1016/j.ajem.2017.06.010 · Cited by 24
“This level of participation can affect readers' opinions regarding the integrity of these CPGs, and some studies have evendocumented that disclosure of industry fundingmay cause readers to downgrade the quality of research and question the outcomes [34-36].”
BackgroundYilmaz, T., Jutten, R. J., Santos, C. Y., Hernandez, K. A., & Snyder, P. J. (2018) · Alzheimer s & Dementia Translational Research & Clinical Interventions · doi:10.1016/j.trci.2018.03.005 · Cited by 24
Industry-funded versus non-profit-funded critical care research: a meta-epidemiological overview
Janiaud, P., Cristea, I. A., & Ioannidis, J. P. A. (2018) · Intensive Care Medicine · doi:10.1007/s00134-018-5325-3 · Cited by 24
Scope and nature of financial conflicts of interest between neurologists and industry
Robbins, N. M., Meyer, M. J., & Bernat, J. L. (2019) · Neurology · doi:10.1212/wnl.0000000000008067 · Cited by 24
Treatment for anemia in people with AIDS
Martí-Carvajal, A. J., Solà, I., Peña-Martí, G. E., & Comunián-Carrasco, G. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004776.pub3 · Cited by 24
State of the art in benefit–risk analysis: Medicines
Luteijn, M., White, B. C., Gunnlaugsdóttir, H., Holm, F., Kalogeras, N., Leino, O., Magnússon, S. H., Odekerken‐Schröder, G., Pohjola, M., Tijhuis, M. J., et al. (2011) · Food and Chemical Toxicology · doi:10.1016/j.fct.2011.06.008 · Cited by 24
“In addition it has been demonstrated that studies sponsored by pharmaceutical companies are four times more likely to favour the product of the sponsor than studies with other sponsors (Lexchin et al., 2003).”
BackgroundSesgos en la edición de las publicaciones científicas
Matías‐Guiu, J., & García-Ramos, R. (2011) · Neurología · doi:10.1016/j.nrl.2010.11.001 · Cited by 27
Tereskerz, P. M. (2003) · Accountability in Research · doi:10.1080/714906093 · Cited by 24
“Likewise, Lexchin et al. (2003) undertook a meta-analysis of 30 studies to assess whether funding of studies by the pharmaceutical industry was associated with outcomes that were favorable to the sponsor and whether the methods were different.”
BackgroundGartlehner, G., Morgan, L. C., Thieda, P., & Fleg, A. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2008.09.019 · Cited by 23
The case against evidence-based principles in psychiatry
Levine, R. A., & Fink, M. (2006) · Medical Hypotheses · doi:10.1016/j.mehy.2006.02.025 · Cited by 24
“This ‘‘file-drawer phenomenon’’ explains, in part, why drug company supported research is four times more likely to produce a positive response than studies from other sources [43].”
BackgroundHemo, B., Endevelt, R., Porath, A., Stampfer, M. J., & Shai, I. (2011) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2011.08.021 · Cited by 25
“[5] Lexchin J, Bero LA, Djulbegovic B, Clark O.”
BackgroundFuture directions for The Spine Journal: managing and reporting conflict of interest issues
Carragee, E. J., Hurwitz, E. L., Weiner, B. K., Bono, C. M., & Rothman, D. J. (2011) · The Spine Journal · doi:10.1016/j.spinee.2011.08.418 · Cited by 24
“Particularly disturbingwere the findings in the rhBMP-2 review that demonstrated awidespread failure to accurately disclose substantial conflicts of interest; trial designs that likely inflated the benefits of rhBMP-2 and exaggerated the morbidity of alternative treatments; and promoted unsupported claims regarding th…”
BackgroundSeitz, D. P., Gill, S. S., & Conn, D. K. (2010) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.2483 · Cited by 23
“Pharmaceutical company sponsorship of trials can influence the reporting of results with exaggerated treatment effects reported in industry-sponsored trials compared to trials sponsored from other sources (Lexchin et al., 2003).”
ResultLiu, X., & Zhu, H. (2023) · Scientometrics · doi:10.1007/s11192-023-04679-5 · Cited by 25
“Thus, in response to pressure such as commercialization, researchers in natural sciences may overemphasize the benefits and ignore the negative outcomes (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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