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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]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
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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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BackgroundUsing collaboration networks to identify authorship dependence in meta‐analysis results
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“1 The origins and consequences of this problem have been extensively described; however, attempts at solutions have so far been insufficient, as recent analyzes of the literature indicate that issues such as publication 2,3 and sponsorship 4 biases are still widespread.”
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“Non-sponsored studies probably have higher credibility (Lexchin et al., 2003), which may explain their larger impact.”
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Karpouzis, F., Bonello, R., Pribicevic, M., Kalamir, A., & Brown, B. T. (2016) · Chiropractic & Manual Therapies · doi:10.1186/s12998-016-0099-6 · Cited by 22
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“Lexchin et al.54 reported that pharmacoeconomic studies sponsored by the industry tended to favour the sponsor’s product; we found similar results.”
ResultIs the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes
Goldacre, B. M. (2009) · BMJ · doi:10.1136/bmj.b4949 · Cited by 19
“comprising distinguished academic clinicians, monitors the analyses and trial results and protects the safety of participants, the credibility of the study, and the validity of results. Indeed, some evidence suggests that industry sponsored studies have higher methodological quality than those funded by other bodies”
BackgroundRedundant, Secretive, and Isolated: When Are Clinical Trials Scientifically Valid?
Borgerson, K. (2014) · Kennedy Institute of Ethics journal · doi:10.1353/ken.2014.0029 · Cited by 21
“Given extraordinarily high rates of publication bias in subsequent years, it is clear that researchers and research ethics committees didn’t see this condition as necessary or didn’t enforce it (lexchin et al. 2003).”
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ResultComparison of veterinary drugs and veterinary homeopathy: part 2
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“However, this association could be because pharmaceutical companies selectively fund trials on drugs they consider to be more effective (Lexchin et al., 2003), or due to selection of the comparative treatment (Bourgeois et al.”
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“Conversely, “ghost” authorship—the omission of an individual who has contributed substantially to a study—has also been discussed as an important ethical issue in the authorship literature KENNEDY INSTITUTE OF ETHICS JOURNAL • SEPTEMBER 2017 [ 376 ] (Anstey 2014; Matías-Guiu and García-Ramos 2011; Mowatt et al. 2002),…”
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To Be Scientific Is To Be Communist
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“…data fabrication or falsification (Doucet and Sismondo 2008; Holman and Elliott 2018), manipulating research designs to engineer favorable outcomes (Lexchin et al. 2003; McGarity and Wagner 2008; Doucet and Sismondo 2008; Elliott and McKaughan 2009; Lundh et al. 2018; Fabbri et al. 2018),…”
BackgroundVeroniki, A. A., Wong, E. K. C., Lunny, C., Molina, J. C. M., Flórez, I. D., Tricco, A. C., & Straus, S. E. (2023) · Systematic Reviews · doi:10.1186/s13643-023-02235-z · Cited by 19
“Discussion Research focused on a specific drug which is funded by the manufacturer of the drug has found to be more prone to producing results favourable to the manufacturer’s intervention [15].”
BackgroundResultPharmaceutical industry and the market: The case of Prozac and other antidepressants
Das, A. (2011) · Asian Journal of Psychiatry · doi:10.1016/j.ajp.2011.01.002 · Cited by 20
Editors, Publishers, Impact Factors, and Reprint Income
Marcovitch, H. (2010) · PLoS Medicine · doi:10.1371/journal.pmed.1000355 · Cited by 19
“More culpable is the fact that studies showing positive outcomes for a drug or device under consideration are more likely to be published than ‘‘negative’’ studies; editors are partly to blame for this but so are commercial sponsors, whose methodologically well-conducted studies with unfavourable results tended not to…”
BackgroundBeyond evidence-based nursing: tools for practice
Jutel, A. (2008) · Journal of Nursing Management · doi:10.1111/j.1365-2834.2008.00861.x · Cited by 19
“…information about conflict of interest in the pharmaceutical industry s involvement in health care (see, for example, Ziegler et al. 1995, Wazana 2000, Steinman et al. 2001, Cooper et al. 2003, Lexchin et al. 2003, Douglas & Sutton 2004, Kaphingst & DeJong 2004, Cardarelli et al. 2006, Healy 2006).”
Defining “quality of care” persuasively
Goldenberg, M. J. (2012) · Metamedicine · doi:10.1007/s11017-012-9230-4 · Cited by 20
Can a good tree bring forth evil fruit? The funding of medical research by industry
Capps, B. (2016) · British Medical Bulletin · doi:10.1093/bmb/ldw014 · Cited by 19
Jin, L., Hua, F., & Cao, Q. (2016) · Lasers in Medical Science · doi:10.1007/s10103-016-2018-4 · Cited by 19
“Besides, if a trial is funded by the industry, its results could be biased in favor of the sponsor [22, 23].”
BackgroundOng, B. Y., & Aziz, Z. (2016) · Complementary Therapies in Medicine · doi:10.1016/j.ctim.2016.12.007 · Cited by 19
Zhang, X., Lan, L., Chan, J. C. P., Zhong, L. L. D., Cheng, C. W., Lam, W.-C., Tian, R., Zhao, C., Wu, T., Shang, H., et al. (2020) · BMC Medical Research Methodology · doi:10.1186/s12874-020-01077-w · Cited by 20
Survey of Conflict-of-Interest Disclosure Policies of Ophthalmology Journals
Anraku, A., Jin, Y.-P., Trope, G. E., & Buys, Y. M. (2009) · Ophthalmology · doi:10.1016/j.ophtha.2008.12.053 · Cited by 19
Sponsorship-Related Outcome Selection Bias in Published Economic Studies of Triptans
Peura, P. K., Martikainen, J. A., Purmonen, T. T., & Turunen, J. H. O. (2011) · Medical Decision Making · doi:10.1177/0272989x11403834 · Cited by 19
Graham, J. (2008) · BioSocieties · doi:10.1017/s1745855208006182 · Cited by 17
“Drug companies contract some 60% of medical researchers (Caulfield, 2001) and the pharmaceutical industry spends more on medical research than the National Institutes of Health in the United States (Lexchin et al., 2003).”
BackgroundActual Usage and Quality of Experimental Colitis Models in Preclinical Efficacy Testing
Zeeff, S. B., Kunne, C., Bouma, G., de Vries, R. B., & Velde, A. A. T. (2016) · Inflammatory Bowel Diseases · doi:10.1097/mib.0000000000000758 · Cited by 20
“A systematic review investigating pharmaceutical industry sponsorship reported a meta-analysis which suggests that some degree of systemic bias concerning the outcome of published research funded by the pharmaceutical industry exists.(35) There are also initiatives attempting to minimize the current publication bias s…”
BackgroundBornay‐Barrachina, M., & Herrero, I. (2017) · Journal of Business and Psychology · doi:10.1007/s10869-017-9495-8 · Cited by 23
“When we interviewed team leaders by telephone, 96% of the interviewees agreed with Nederhof (2006), Lexchin et al. (2003) and Payne (1987, 1990) that innovative and original results could be measured by the number of published papers.”
BackgroundMental health nursing students’ relationships with the pharmaceutical industry
Ashmore, R., Carver, N., & Banks, D. (2006) · Nurse Education Today · doi:10.1016/j.nedt.2006.08.016 · Cited by 19
“In recent years a wide body of academic literature examining the influence of the pharmaceutical industry on the medical profession has emerged (cf. Abbasi and Smith, 2003; Lexchin et al., 2003; Melander et al., 2003).”
BackgroundCanada’s Stem Cell Corporation: Aggregate Concerns and the Question of Public Trust
Herder, M., & Brian, J. (2007) · Journal of Business Ethics · doi:10.1007/s10551-006-9294-z · Cited by 19
Litigation-Generated Science: Why Should We Care?
Boden, L. I., & Ozonoff, D. M. (2007) · Environmental Health Perspectives · doi:10.1289/ehp.9987 · Cited by 19
“…studies by researchers without financial conflicts of interest, such studies have been found to have conclusions more favorable to the companies funding them (Als-Nielsen et al. 2003; Bekelman et al. 2003; Friedman and Richter 2004; Lexchin et al. 2003; Perlis et al. 2005; Stelfox et al. 1998).”
BackgroundResultMiller, F. G., & Brody, H. A. (2005) · Academic Medicine · doi:10.1097/00001888-200510000-00005 · Cited by 19
Chen, L., Ashcroft, D. M., & Elliott, R. A. (2007) · Pharmacy World & Science · doi:10.1007/s11096-007-9125-z · Cited by 19
“The interviewees highlighted problems with industry-led economic studies, such as using indirect comparisons, nonrelevant outcome measures, and selectively reporting positive results, mirroring previous research findings [19–21].”
ResultConflicts of Interest in GM Bt Crop Efficacy and Durability Studies
Guillemaud, T., Lombaert, E., & Bourguet, D. (2016) · PLOS ONE · doi:10.1371/journal.pone.0167777 · Cited by 18
Coles, N. A., Larsen, J. T., Kuribayashi, J., & Kuelz, A. (2019) · Emotion Review · doi:10.1177/1754073919868762 · Cited by 22
Standardised data on initiatives—STARDIT: Beta version
Nunn, J., Shafee, T. M. A., Chang, S., Stephens, R., Elliott, J., Oliver, S. R., John, D., Smith, M. P., Orr, N., Preston, J., et al. (2022) · Research Involvement and Engagement · doi:10.1186/s40900-022-00363-9 · Cited by 17
“Medicine’s Medical Subject Headings (MeSH), which are used extensively in multiple kinds of literature reviews [38].”
The impact of selective publication on clinical research in pain
Rowbotham, M. C. (2008) · Pain · doi:10.1016/j.pain.2008.10.026 · Cited by 19
“[12] Lexchin J, Bero LA, Djulbegovic B, Clark O.”
BackgroundRodríguez, E. L. R. (2011) · Acta bioethica · doi:10.4067/s1726-569x2011000100006 · Cited by 19
“Una encuesta reciente subraya que el conflicto de intereses es “dominante y problemático” en la investigación biomédica, ya que una cuarta parte de investigadores universitarios reciben fondos de la industria y una tercera tiene vínculos financieros con los patrocinadores(14).”
BackgroundQuantifying indirect evidence in network meta‐analysis
Noma, H., Tanaka, S., Matsui, S., Cipriani, A., & Furukawa, T. A. (2016) · Statistics in Medicine · doi:10.1002/sim.7187 · Cited by 18
“One of the wellknown relevant biases would be industry sponsorship bias [19].”
BackgroundOliver, A. L., & Sapir, A. (2016) · Journal of Professions and Organization · doi:10.1093/jpo/jow012 · Cited by 18
Impact of funding on biomedical research: a retrospective cohort study
Decullier, É., & Chapuis, F. R. (2006) · BMC Public Health · doi:10.1186/1471-2458-6-165 · Cited by 18
“Our study was not designed to answer this question, moreover the small number of completed protocols with private fundings did not allow to see if this research was more likely to produce significant results as shown in other papers[26,27].”
ResultWilkes, S. R., Nankervis, H., Tavernier, E., Maruani, A., & Williams, H. C. (2016) · Journal of Investigative Dermatology · doi:10.1016/j.jid.2016.05.104 · Cited by 18
“Several studies have demonstrated that RCTs sponsored by industry are more likely to produce results in favour of the product made by that company (Katz et al., 2006; Lexchin et al., 2003).”
BackgroundSchünemann, H. J. (2011) · Current Allergy and Asthma Reports · doi:10.1007/s11882-011-0185-8 · Cited by 18
“That COI can misinform health care decision makers is widely recognized [19, 20 ].”
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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