P.Mean >> Category >> Conflict of interest (created 2007-06-11).

Conflict of interest represents an outside influence, usually financial, that has the potential to upset the balance of impartiality that is important in credible research. Articles are arranged by date with the most recent entries at the top. Also see Category: Corroborating evidence, Category: Ethics in research, Category: Fraud in research. You can find outside resources at the bottom of this page.

2011

19. P.Mean: Positive statements about no conflicts of interest (created 2011-08-16). There is a lot of confusion about when you can report "No conflict of interest." You don't know whether this means that there is no financial relationship with any pharmaceutical product, with a phamaceutical product named in the paper, or with competitors to pharmaceutical products named in the paper. You don't know if the person making the claim about no conflict has gotten money from a drug company, but believes that this does not influlence his/her perspective. I believe that the no conflict statement should be replaced with something far more specific. Here are some examples.

18. P.Mean: Banning editorials and clinical reviews from authors with industry ties (created 2011-08-13). BMJ published a commentary on conflict of interest policies that ended with the question "should the BMJ ... ban editorials and clinical reviews from authors with ties to industry?" Here's my response to that question.

17. The Monthly Mean: Conflict of interest disclosures (December 2010)

2009

16. P.Mean: Institute of Medicine report on conflict of interest (created 2009-05-24). The National Academies Press has announced the release of a report, Conflict of Interest in Medical Research, Education, and Practice, prepared by a special committee of the Institute of Medicine.

2008

15. The Monthly Mean: Private conflicts of interest. (November 2008) and P.Mean: Evaluating private conflicts of interest (created 2008-10-01). The open source journal PLoS Medicine has an interesting editorial that is worth commenting on. Making Sense of Non-Financial Competing Interests. The PLoS Medicine Editors. PLoS Med 5(9): e199 doi:10.1371/journal.pmed.0050199.

Outside resources:

American Association of University Professors. Academe: The Conflicted University. Excerpt: "“The Conflicted University” examines the endangered future of independent, transparent research for the common good at universities across the country. Guest editor Sheldon Krimsky, one of the nation’s experts in scientific conflicts of interest, teamed up with Academe editor Cat Warren to create this expanded issue of Academe. In this special issue, a group of internationally respected academics, science journalists, and other experts tackle what have become some of the thorniest issues facing higher education: corporate conflicts of interest, the chilling of scientific speech and academic freedom, and the urgent need to protect the integrity of scientific research." [Accessed November 10, 2010]. Available at: http://www.aaup.org/AAUP/pubsres/academe/2010/ND/.

Nathan D, Weatheral D. Academic Freedom in Clinical Research. New England Journal of Medicine. 2002;347:1368-1371. Available at: http://content.nejm.org/cgi/content/extract/347/17/1368 [Accessed March 9, 2009]. Description: This article summarizes the Nancy Oliveri case. Dr. Olivieri was a researcher who was determined to present information about safety problems with a drug she was studying, in violation of a confidentiality agreement with the drug company that sponsored the research. This case illustrates the need to avoid agreements with drug companies that allow those companies to completely bar publication of unfavorable results.

Moses H, Martin JB. Academic Relationships With Industry: A New Model for Biomedical Research. Journal of the American Medical Association. 2001;285:933-935. Available at: http://jama.ama-assn.org/cgi/content/extract/285/7/933 [Accessed March 9, 2009]. Description: This article proposes several general principles for managing the increasingly complex financial ties between academic research institutions and industry.

Krimsky S, Ennis JG, Weissman R. Academic-corporate ties in biotechnology: a quantitative study. Sci Technol Human Values. 1991;16(3):275-87.  [Accessed March 9, 2009].

Journal article: Dana Katz, Arthur L Caplan, Jon F Merz. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving Am J Bioeth. 2003;3(3):39-46. Abstract: "Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated." [Accessed on August 16, 2011]. http://sitemaker.umich.edu/emjournalclub/article_database/da.data/716908/PDF/small_gifts_ajob.pdf.

Journal article: Elizabeth A. Boyd, Lisa A. Bero. Assessing Faculty Financial Relationships With Industry JAMA: The Journal of the American Medical Association. 2000;284(17):2209 -2214. Description: This article summarizes the financial relationships that faculty members at the University of California, San Francisco have with external sponsors of clinical research. This occurs about 8% of the time. The finncial relationships typically involve paid speaking engagements and consulting agreements. A smaller proportion involved equity holding or participation on an advisory board. Abstract "Context: A growing number of academic researchers receive industry funding for clinical and basic research, but little is known about the personal financial relationships of researchers with their industry sponsors. Objectives: To assess the extent to which faculty researchers have personal financial relationships with the sponsors of their research, the nature of those financial relationships, and efforts made at the institutional level to address disclosed financial relationships and perceived conflicts of interest. Design and Setting: Case study of the University of California, San Francisco (UCSF). Data sources included disclosure forms and official documents maintained by the UCSF Office of Research Administration from December 1980 to October 1999, including decisions made by the UCSF Chancellor's Advisory Panel on Relations with Industry. Main Outcome Measures: Number and types of personal financial relationships with external sponsors (positive financial disclosures from all clinical, basic, or social science faculty who were principal investigators), amount of annual income received from sponsors, and decisions and management strategies used by the advisory panel. Results: By 1999, almost 7.6% of faculty investigators reported personal financial ties with sponsors of their research. Throughout the study period, 34% of disclosed relationships involved paid speaking engagements (range, $250–$20,000 per year), 33% involved consulting agreements between researcher and sponsor (range, <$1000–$120,000 per year), and 32% involved the investigator holding a position on a scientific advisory board or board of directors. Fourteen percent involved equity ownership, and 12% involved multiple relationships. The advisory panel recommended managing perceived conflicts of interest in 26% of the cases, including recommending the sale of stock, refusing additional payment for talks, resigning from a management position, or naming a new principal investigator for a project. Conclusions: Faculty researchers are increasingly involved in financial relationships with their research sponsors. Guidelines for what constitutes a conflict and how the conflict should be managed are needed if researchers are to have consistent standards of behavior among institutions." [Accessed on August 16, 2011]. http://jama.ama-assn.org/content/284/17/2209.abstract.

Journal article: L. L Kjaergard. Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ BMJ. 2002;325(7358):249-249. Description: This article notes that publications noting financial competing interests led to different reporting results compared to publications reporting no competing interests. This effect could not be explained by methodological quality or other factors. Interestingly, publications reporting other types of competing interests did not differ in reporting results. Abstract "Objective: To assess the association between competing interests and authors' conclusions in randomised clinical trials. Design: Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. Studies: 159 trials from 12 medical specialties. Main outcome measures: Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention. Results: Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. Conclusions: Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions." [Accessed on April 4, 2011]. http://www.bmj.com/cgi/doi/10.1136/bmj.325.7358.249.

Yaphe, J., R. Edman, B. Knishkowy, and J. Herman. 2001. The association between funding by commercial interests and study outcome in randomized controlled drug trials. Fam Pract 18 (6):565-8.

Leopold, S. S., W. J. Warme, E. Fritz Braunlich, and S. Shott. 2003. Association between funding source and study outcome in orthopaedic research. Clin Orthop Relat Res (415):293-301.

Wang AT, McCoy CP, Murad MH, Montori VM. Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review. BMJ. 2010 Mar 18;340:c1344.

Journal article: Bodil Als-Nielsen, Wendong Chen, Christian Gluud, Lise L. Kjaergard. Association of Funding and Conclusions in Randomized Drug Trials JAMA: The Journal of the American Medical Association. 2003;290(7):921 -928. Description: This article provides evidence that randomized trials sponsored by industry are more likley to report results favorable to the sponsoring company and compares these results to other studies looking at this issue. Abstract "Context: Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions.Objective To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events. Design: Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication). Main Outcome Measure: Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not. Results: The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; ?2 test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events. Conclusions: Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data." [Accessed on August 16, 2011]. http://jama.ama-assn.org/content/290/7/921.abstract.

Journal article: Mohit Bhandari, Jason W. Busse, Dianne Jackowski, Victor M. Montori, Holger Schünemann, Sheila Sprague, Derek Mears, Emil H. Schemitsch, Dianne Heels-Ansdell, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials Canadian Medical Association Journal. 2004;170(4):477 -480. Description: This article provides evidence that randomized trials sponsored by industry are more likely to report results favorable to the sponsoring company and compares these results to other studies looking at this issue. Abstract: "Background: Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings. In this study, we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials.Methods: We examined a consecutive series of 332 randomized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals. Each eligible study was independently reviewed for methodological quality using a 21-point index with 5 domains: randomization, outcomes, eligibility criteria, interventions and statistical issues. Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant. For studies that did not explicitly identify a primary outcome, we defined a 'positive' study as one with at least 1 statistically significant outcome measure. We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results, while controlling for study quality and sample size.Results: Among the 332 randomized trials, there were 158 drug trials, 87 surgical trials and 87 trials of other therapies. In 122 (37%) of the trials, authors declared industry funding. An unadjusted analysis of this sample of trials revealed that industry funding was associated with a statistically significant result in favour of the new industry product (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.3–3.5). The association remained significant after adjustment for study quality and sample size (adjusted OR 1.8, 95% CI 1.1–3.0). There was a nonsignificant difference between surgical trials (OR 8.0, 95% CI 1.1–53.2) and drug trials (OR 1.6, 95% CI 1.1–2.8), both of which were likely to have a pro-industry result (relative OR 5.0, 95% CI 0.7–37.5, p = 0.14).Interpretation: Industry-funded trials are more likely to be associated with statistically significant pro-industry findings, both in medical trials and surgical interventions." [Accessed on August 16, 2011]. http://www.cmaj.ca/content/170/4/477.abstract.

Journal article: A R Feinstein, R I Horwitz. Avoiding conflicts of interest in drug research N. Engl. J. Med. 1979;301(18):1009. [Accessed on August 16, 2011]. http://www.ncbi.nlm.nih.gov/pubmed/492227.

R. Sykes. Being a modern pharmaceutical company: involves making information available on clinical trial programmes. British Medical Journal 1998: 317(7167); 1172. [Medline] [Full text] [PDF]. Description: This article highlights the policy at GlaxoWellcome to register information on all the clinical trials that it conducts.

R Smith. Beyond conflict of interest. Transparency is the key [editorial]. Bmj 1998: 317(7154); 291-2. [Full text] [PDF]. Description: This article presents the case that conflict of interest is more than a theoretical concern and outlines changes in the conflict of interest policy at BMJ. 

D. L. Sackett. Bias in analytic research. J Chronic Dis 1979: 32(1-2); 51-63. [Medline].

Lanier WL. Bidirectional Conflicts of Interest Involving Industry and Medical Journals: Who Will Champion Integrity? Mayo Clinic Proceedings. 2009;84(9):771-775. Excerpt: In the current issue of the Proceedings, the journal adds to its collection one more COI article that has passed the journal's stringent peer-review standards. In his commentary, Dr Laurence Hirsch, a part-time practicing endocrinologist, former employee of Merck & Co and current employee of another biomedical company contributor to the Pharmaceutical Manufacturers Association (PhRMA) guidelines on publication standards, and former president of the International Society for Medical Publishing Professionals (ISMPP), argues that journals and journal editors have compromised their credibility as adjudicators of COI and, although likely unintentionally, have abetted plaintiffs' lawyers to the detriment of the pharmaceutical industry. Specifically, Hirsch argues that journal editors sometimes use one set of COI standards for accepting or rejecting manuscripts when it suits their purposes and another set of standards when it does not. Available at: http://www.mayoclinicproceedings.com/content/84/9/771.short [Accessed September 3, 2009].

S Scarr, CB Ernhart. Blood lead levels, scientific misconduct and the Needleman case. 3. A reply from Scarr and Ernhart. Am J Public Health 1996: 86(1); 113-4; author reply 114-5. [Medline].

Jorgensen, A. W., J. Hilden, and P. C. Gotzsche. 2006. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. BMJ 333 (7572):782.

Hundley K. Companies run trials of drugs they invest in. St. Petersburg Times. 2007. Available at: http://www.sptimes.com/2007/07/01/Worldandnation/Companies_run_trials_.shtml [Accessed March 9, 2009].

S. Krimsky. Conflict of interest and cost-effectiveness analysis. Jama 1999: 282(15); 1474-5. [Medline] [Abstract]. Description: This article reviews the viewpoints for an against disclosing financial conflicts of interest. Then the author summarizes a research publication of the influence of financial support in studies of cost effectiveness

CD DeAngelis. Conflict of interest and the public trust. CD DeAngelis. JAMA 2000: 284(17); 2237-2238. [Medline] [Abstract]. Description: This article summarizes an issue of JAMA devoted to conflict of interest issues. The authors note the problems with industry support of research, but argue that it is untenable to simply ban industry funding.

M. L. Elks. Conflict of interest and the physician-researcher. J Lab Clin Med 1995: 126(1); 19-23. [Medline]. Description: This article suggests that indirect research support may undermine the investigator's role to serve first as an advocate for his/her patient.

HT Stelfox, G Chua, K O'Rourke, AS Detsky. Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 1998: 338(2); 101-6. [Medline]. This article is cited in Category: ConflictOfInterest. Description: This article reviews a series of publications examining the safety of calcium channel antogonists. Authors were more likely to have a financial ties if their articles were positive towards calcium-channel antagonists than those neutral or critical.

Hirsch LJ. Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals. Mayo Clinic Proceedings. 2009;84(9):811-821. Excerpt: In recent years, Mayo Clinic Proceedings has published a variety of articles dealing with important, broad-reaching matters of societal interest that impact medicine and patient care. Topics included ideal physician behaviors, gender and medical career mentoring, advance directives and end-of-life issues, physician involvement in capital punishment, and, germane to this article, institutional conflicts of interest (COIs), as well as the journal's approach to publication of industry-sponsored clinical research. Equally important to the well-being of patients and of medicine is the legitimacy of interactions between industry sponsors of research and investigator-authors who communicate the information and the journals/editors who review and ultimately determine publication of the material. In this age of transparency, disclosure of COIs has assumed great prominence in medical journals. However, transparency is not always clear, disclosure policies are varied, and their implementation (by journals and medical societies) is asymmetric and biased. This commentary examines some prominent recent actions by consultants to plaintiffs' attorneys and a series of publications in 3 top-tier general medical journals that illustrate selective and incomplete disclosure of conflicts—both financial and otherwise. In my view, these events call into question actions by a medical specialty society with one of the consultants and, more broadly, the editorial practices at the journals concerning COIs. Specific recommendations are offered to address the latter. Available at: http://www.mayoclinicproceedings.com/content/84/9/811.short [Accessed September 3, 2009].

Journal article: Richard Smith. Conflicts of interest: how money clouds objectivity J R Soc Med. 2006;99(6):292-297. Excerpt: "I want to begin this article with a fantasy, one that has a powerful hold in the minds of many. Doctors treat patients using simply the best evidence and their experience. They are not influenced by money or self interest. Similarly, researchers try to answer the important questions in medicine; specialist societies are concerned only with what is best for a population of patients; and editors of journals publish only what is true and important for medicine. Unlike people who work in the venal worlds of commerce, politics, or journalism we in healthcare are untainted by money and `the pursuit', in the words of Sigmund Freud, `... of fame and the love of beautiful women (or perhaps men)'. This is, of course, nonsense. Those who work in healthcare are human beings and just as prone as any other humans to acting in their own interest; responding to economic incentives, and stumbling into frank fraud and corruption. Anybody who has knocked around in the world and read Dante, Juvenal, Balzac and Dickens knows that this is how human beings behave. Yet somehow in medicine we have fallen prey to the fantasy that we are superhuman. We are not. We are exposed to conflicts of interest, like everybody else. Our response should not be to pretend that they do not exist, but rather to acknowledge and disclose them always—and sometimes to accept that they are so extreme that the doctor should not treat a particular patient or an author write an editorial in a medical journal." [Accessed on November 16, 2011]. Available at http://jrsm.rsmjournals.com/content/99/6/292.full

John Tierney. Corporate Backing for Research? Get Over It. The New York Times. 2010. Excerpt: "Conflict-of-interest accusations have become the simplest strategy for avoiding a substantive debate. The growing obsession with following the money too often leads to nothing but cheap ad hominem attacks." [Accessed January 26, 2010]. Available at: http://www.nytimes.com/2010/01/26/science/26tier.html

Webpage: Center for Science in the Public Interest. CSPI Calls on Journals to Strengthen Disclosure of Conflicts Excerpt: "The Center for Science in the Public Interest (CSPI) is calling on the editors of Science and Nature, the world's two most prestigious science publications, to strengthen their conflict-of-interest disclosure policies. " [Accessed on January 17, 2012]. Avialble at: http://www.cspinet.org/integrity/press/200601121.html

S Schroter, J Morris, S Chaudhry, R Smith, H Barratt. Does the type of competing interest statement affect readers' perceptions of the credibility of research? Randomised trial. BMJ 2004: 328(7442); 742-3. [Medline] [Full text] [PDF]. Excerpt: Financial relationships among industry and academic institutions are diverse and common. These interests can influence authors' conclusions and readers' perceptions of published studies. We report the effects on reader perceptions of different statements of competing interests for two manuscripts.

Bero, L., F. Oostvogel, P. Bacchetti, and K. Lee. 2007. Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others. PLoS Med 4 (6):e184.

Glen Spielmans, Peter Parry. From Evidence-based Medicine to Marketing-based Medicine: Evidence from Internal Industry Documents. Journal of Bioethical Inquiry. Abstract: "While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering and market segmentation of physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality." [Accessed February 3, 2010]. Available at: http://freepdfhosting.com/ebaef05bfe.pdf.

Brody H. Fairness in Enforcing COI Regs by Journals, and Many Other Things Also. Excerpt: Laurence J. Hirsch, MD used to manage the Medical Communications Department for clinical research publications at Merck (2001-2006). He now works for a device company. This post concerns a paper he just published in the Mayo Clinic Proceedings. Available at: http://brodyhooked.blogspot.com/2009/09/fairness-in-enforcing-coi-regs-by.html [Accessed September 3, 2009].

Schott G, Pachl H, Limbach U, Gundert-Remy U, Ludwig WD, Lieb K. The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials. Dtsch Arztebl Int. 2010 Apr;107(16):279-85.

Goozner M. GoozNews: States Say Medscape CME Part of Off-Label Promotion Scheme. Available at: http://www.gooznews.com/archives/001345.html [Accessed March 9, 2009].

O Thomas, L Thabane, J Douketis, et al. Industry funding and the reporting quality of large long-term weight loss trials. Int J Obes. 2008;32(10):1531-1536. Description: This article does not have full free text available, so I can only comment on the abstract. It appears that industry funded studies tend to adhere more closely to the CONSORT reporting guidelines. I suspect that peer-reviewers are more cautious with industry funded studies and demand more detailed reporting of results. The conclusion in the abstract "Our findings suggest that the efforts to improve reporting quality be directed to all obesity RCTs, irrespective of funding source." seems to suggest that peer reviewers need to hold unfunded studies to the same standards as they hold funded studies to. [Accessed January 26, 2010]. Available at: http://dx.doi.org/10.1038/ijo.2008.137.

Angell M. Is academic medicine for sale? N Engl J Med 2000: 342(20); 1516-8. [Medline] [Full text].

Sheldon Krimsky. Journal Policies on Conflict of Interest: If This Is the Therapy, What's the Disease? Psychotherapy and Psychosomatics 2001: 70; 155-117. [Medline] [PDF]. Description: This article criticizes the policies that most journals have for reporting conflicts of interest.

The PLoS Medicine Editors. Making Sense of Non-Financial Competing Interests. PLoS Med. 2008;5(9):e199. Excerpt: "Non-financial competing interests (sometimes called “private interests”) can be personal, political, academic, ideological, or religious. Like financial interests, they can influence professional judgment. Much as we'd like to believe that the reporting and evaluation of research are always objective, there is substantial evidence to the contrary. Like all human activity, academic research and scientific publishing are inherently subjective, imperfect, and prone to bias, corruption, and self-interest. Indeed, because professional affinities and rivalries, nepotism, scientific or technological competition, religious beliefs, and political or ideological views are often the fuels for our passions and for our careers, private competing interests are perhaps even more potent than financial ones." [Accessed November 24, 2010]. Available at: http://dx.doi.org/10.1371/journal.pmed.0050199.

Poses R. A New Perspective on Evaluating the Effects of Financial Conflict of Interest on Research. Excerpt: I just posted about an article from the August issue of the Journal of Epidemiology and Community Health (link here, requires subscription.) Health Care Renewal readers may want to peruse this issue, which has some very interesting articles on conflicts of interest and related issues in research. In particular, an article by Prof Sander Greenland offers a fresh discussion based on perspectives from epidemiology, statistics, and cognitive psychology of the effects of financial conflicts of interest (COI) on (clinical, epidemiological, and health services) research (Greenland S. Accounting for uncertainty about investigator bias: disclosure is informative. J Epidemiol Community Health 2009; 63: 593-598. Link here, requires subscription.) Since only subscribers can easily get this article, and because of its importance, let me summarize its main points and provide appropriate quotations. Available at: http://hcrenewal.blogspot.com/2009/09/new-perspective-on-evaluating-effects.html [Accessed September 3, 2009].

Journal article: Richard Smith, Ian Roberts. Patient safety requires a new way to publish clinical trials PLoS Clin Trials. 2006;1(1):e6. Excerpt: "The way medical journals publish the results of clinical trials has become a serious threat to public health. You may find this assertion shocking and counterintuitive, but we hope that by the end of this short article you will agree and will join us in arguing for the better way of making medical information publicly available that we outline." [Accessed on November 16, 2011]. Available at http://clinicaltrials.ploshubs.org/article/info:doi/10.1371/journal.pctr.0010006

Sismondo S. Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemp Clin Trials. 2008 Mar;29(2):109-13.

Lexchin, J., L. A. Bero, B. Djulbegovic, and O. Clark. 2003. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326 (7400):1167-70.

American Society of Gene Therapy. Policy/Position Statement. Policy of The American Society of Gene Therapy Financial Conflict of Interest in Clinical Research. Adopted April 5, 2000. Available at: http://ccnmtl.columbia.edu/projects/rcr/rcr_conflicts/misc/Ref/AGST_CoI.pdf

Association of American Medical Colleges. Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research. Available at: http://ccnmtl.columbia.edu/projects/rcr/rcr_conflicts/misc/Ref/AAMC_2002CoIReport.pdf

Jefferson T, Di Pietrantonj C, Debalini MG, Rivetti A, Demicheli V. Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review. BMJ. 2009;338(feb12_2):b354. Available at: http://www.bmj.com/cgi/content/abstract/338/feb12_2/b354 [Accessed March 31, 2009].

Association of American Universities. Report on Individual and Institutional Financial Conflict of Interest, October 2001. Available at http://ccnmtl.columbia.edu/projects/rcr/rcr_conflicts/misc/Ref/AAU_CoI.pdf

Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010 May 26;303(20):2058-64.

American Society of Clinical Oncology. Revised Conflict of Interest Policy. Available at: http://ccnmtl.columbia.edu/projects/rcr/rcr_conflicts/misc/Ref/JCO_CoI.pdf

Journal article: Justin E Bekelman, Yan Li, Cary P Gross. Scope and impact of financial conflicts of interest in biomedical research: a systematic review JAMA. 2003;289(4):454-465. Abstract: "CONTEXT: Despite increasing awareness about the potential impact of financial conflicts of interest on biomedical research, no comprehensive synthesis of the body of evidence relating to financial conflicts of interest has been performed. OBJECTIVE: To review original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research. DATA SOURCES: Studies were identified by searching MEDLINE (January 1980-October 2002), the Web of Science citation database, references of articles, letters, commentaries, editorials, and books and by contacting experts. STUDY SELECTION: All English-language studies containing original, quantitative data on financial relationships among industry, scientific investigators, and academic institutions were included. A total of 1664 citations were screened, 144 potentially eligible full articles were retrieved, and 37 studies met our inclusion criteria. DATA EXTRACTION: One investigator (J.E.B.) extracted data from each of the 37 studies. The main outcomes were the prevalence of specific types of industry relationships, the relation between industry sponsorship and study outcome or investigator behavior, and the process for disclosure, review, and management of financial conflicts of interest. DATA SYNTHESIS: Approximately one fourth of investigators have industry affiliations, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions. Eight articles, which together evaluated 1140 original studies, assessed the relation between industry sponsorship and outcome in original research. Aggregating the results of these articles showed a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also associated with restrictions on publication and data sharing. The approach to managing financial conflicts varied substantially across academic institutions and peer-reviewed journals. CONCLUSIONS: Financial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways." [Accessed on November 16, 2011]. Available at http://jama.ama-assn.org/content/289/4/454.long

Journal article: Hilda Bastian. "They would say that, wouldnt they?" A reader's guide to author and sponsor biases in clinical research J R Soc Med. 2006;99(12):611-614. Excerpt: "Commercial sponsorship of clinical research, especially for drugs, is ubiquitous. One of the solutions to some of the dilemmas arising from this is full disclosure of authors' financial interests and relationships with sponsors. But is disclosure enough, and what should we as readers make of the fine print at the end of journal articles? Is sponsorship bias the only bias we should watch out for?" [Accessed on August 16, 2011]. http://jrsm.rsmjournals.com.

  1. Conflict of interest and the American Journal of Bioethics Description: Coming soon!
  2. Fear and loathing of pharmaceutical statistics
  3. Operating the smokescreen
  4. Cholesterol lowering trials in coronary heart disease: frequency of citation and outcome
  5. Conflict-of-interest policies for investigators in clinical trials
  6. Conflict of interest policies in science and medical journals: editorial practices and author disclosures
  7. Declaring financial competing interests: survey of five general medical journals
  8. Deficits in psychologic and classroom performance of children with elevated dentine lead levels
  9. Disclosure and Disinterest
  10. Disclosure policies for gifts from industry to academic faculty
  11. Disclosure of Authors' Conflicts of Interest: A Follow-up
  12. Does the type of competing interest statement affect readers' perceptions of the credibility of research? Randomised trial
  13. Economic incentives in clinical investigation
  14. Editorials and Conflicts of Interest
  15. Efficacy and safety of antidepressants for children and adolescents
  16. Environmental lead and children's intelligence
  17. Ethics issues in academic-industry relationships in the life sciences: the continuing debate
  18. Evaluation of conflict of interest in economic analyses of new drugs used in oncology
  19. Financial Associations of Authors
  20. Financial interest and its disclosure in scientific publications
  21. Financial interests of authors in scientific journals: a pilot study of 14 publications
  22. Financial Conflict-of-Interest Policies in Clinical Research: Issues for Clinical Investigators
  23. Funding source, trial outcome and reporting quality: are they related? Results of a pilot study
  24. Get-the-lead-out guru challenged
  25. How can research ethics committees protect patients better?
  26. Influences on the Quality of Published Drug Studies
  27. Institutions, Contracts, and Academic Freedom
  28. Lung cancer and passive smoking. Turning over the wrong stone
  29. National office of drug safety is needed, experts say in JAMA
  30. New England Journal loosens its rules on conflict of interest
  31. Nonfinancial conflicts of interest in research
  32. Of whistleblowers, investigators, and judges
  33. On being a whistleblower: the Needleman case
  34. Operating the smokescreen
  35. Participation of life-science faculty in research relationships with industry
  36. Pharmaceutical industry sponsorship and research outcome and quality: systematic review
  37. Policies on faculty conflicts of interest at US universities
  38. Potential solutions to the problem of conducting systematic reviews of new health technologies
  39. Print media coverage of research on passive smoking
  40. Problem is greater than editorial indicates
  41. The publication of sponsored symposiums in medical journals
  42. The Quality of Drug Studies Published in Symposium Proceedings
  43. Reanalysis of epidemiological evidence on lung cancer and passive smoking
  44. Relationships between academic institutions and industry in the life sciences--an industry survey
  45. Reference bias in reports of drug trials
  46. Relationships between authors of clinical practice guidelines and the pharmaceutical industry
  47. Reply to Ernhart, Scarr, and Geneson
  48. A reply to Scarr and Ernhart
  49. Review of the quality of studies on the economic effects of smoke-free policies on the hospitality industry
  50. Salem comes to the National Institutes of Health: notes from inside the crucible of scientific integrity
  51. Scientific journals and their authors' financial interests: a pilot study
  52. Source of funding and outcome of clinical trials
  53. Sponsorship, Authorship and Accountability
  54. A Study of Manufacturer-Supported Trials of Nonsteroidal Anti-inflammatory Drugs in the Treatment of Arthritis
  55. Systematic reviews and meta-analyses on treatment of asthma: critical evaluation
  56. Tobacco Industry Efforts to Defeat the Occupational Safety and Health Administration Indoor Air Quality Rule
  57. Tobacco industry research: collaboration, not confrontation, is the best approach
  58. The uncertainty principle and industry-sponsored research
  59. Uneasy Alliance - Clinical Investigators and the Pharmaceutical Industry
  60. What scientists funded by the tobacco industry believe about the hazards of cigarette smoking
  61. When commitments and interests conflict. "There's probably no greater conflict of interest than an NIH grant"
  62. Why Review Articles on the Health Effects of Passive Smoking Reach Different Conclusions

Creative Commons License All of the material above this paragraph is licensed under a Creative Commons Attribution 3.0 United States License. This page was written by Steve Simon and was last modified on 2010-04-11. The material below this paragraph links to my old website, StATS. Although I wrote all of the material listed below, my ex-employer, Children's Mercy Hospital, has claimed copyright ownership of this material. The brief excerpts shown here are included under the fair use provisions of U.S. Copyright laws.

2007

14. Stats: Reforming conflict of interest statements (November 12, 2007). In a recent talk, I was asked to disclose any conflicts of interest. I did so, but I also commented that the organization I was speaking to, as well as most other organizations have a poorly thought out conflict of interest policy. The problem with most of these policies is that they make it hard to disclose conflicts and easy to pretend that no conflicts exist. I believe that rather than having an easy box to check, make the statement of no conflict a more detailed one.

13. Stats: Does promoting your book constitute a conflict of interest? (August 13, 2007). I give lots of talks and I usually put in a plug for my book, Statistical Evidence in Medical Trials. I even promote my book in the signature file that I put at the bottom of all my emails. My philosophy is that if you don't promote yourself, who will? I got an interesting email from someone associated with the Continuing Medical Education (CME) department of a site where I will be giving a talk that very politely called me to task for this self-promotion.

12. Stats: Need for a conflict of interest policy (August 9, 2007). I attended a very interesting session at the Joint Statistical Meetings last week on conflict of interest. I asked a question during the session that seemed quite obvious to me at the time, but which was apparently not thought of by any of the speakers. Why did no one in that session formally declare whether they had a conflict of interest?

11. Stats: Conflict of interest in the Wakefield MMR study (July 26, 2007). An interesting case study in conflict of interest (perhaps a bit too complex to be described fairly in this brief weblog entry) involves a controversial paper. The lead author of this paper, Wakefield A; Murch S, Anthony A, Linnell J, Casson D, Malik M, Berelowitz M, Dhillon A, Thomson M, Harvey P, Valentine A, Davies S, Walker-Smith J (February 28 1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children 637-641. The Lancet - Vol. 351, Issue 9103. DOI:10.1016/S0140-6736(97)11096-0, is Andrew Wakefield. Dr. Wakefield has alleged on the basis of twelve children referred to his clinic that there was a link between the MMR vaccine and the development of autism.

10. Stats: Conflict of interest list (July 18, 2007). I was asked to fill out a conflict of interest form for a talk I will be giving in December. While I have not gotten any money directly from drug companies recently, I do have some financial support outside the hospital that might be considered a conflict of interest in some contexts. These sources of support do not relate directly or indirectly to the topic I will be discussing in December (or any of the topics that I plan to discuss), but it it better to disclose too much rather than too little. I will try to update this page as new sources of support appear.

9. Stats: Manipulation of peer-review publications by pharmaceutical companies (March 9, 2007). This weblog entry provides some discussion points that I want to share in a seminar: Stats #72: Manipulation of peer-review publications by pharmaceutical companies

8. Stats: PharmedOUT website (March 2, 2007). In response to educational resources in medicine that are dominated by drug company support, a  new website, PharmedOUT, has been formed, www.pharmedout.org/index.htm.

2006 

7. Stats: When can a conservative trust a liberal information source (and vice versa) (July 10, 2006). I have a brother-in-law who loves to debate politics and religion. He always takes an aggressively conservative stand (I'm a flaming liberal, but try not to mention politics too much on this weblog). Often he will cite a "liberal" source, such as the New York Times to support his arguments, and although he does not trust most of what is published in these liberal sources, he will still cite them when they make a point in favor of a conservative viewpoint. His rationale is when a liberal source cites data supporting a conservative cause, they only do it grudgingly and because the facts are too overwhelming to ignore. I suppose I do the same thing myself, but with the politics reversed. But this is a dangerous approach to take for several reasons.

6. Stats: What constitutes a conflict of interest? (May 4, 2006). I am a member of a committee that helps researchers set up Data Safety and Monitoring Boards (DSMBs) for research projects at Kansas University Medical Center (KUMC). The typical study that we would help set up DSMBs for would be small scale single center trials. We recommended that the typical DSMB have two specialists in the medical area of the research and a statistician. We ask the principal investigator to nominate the two specialists. Some debate ensued about whether the specialists nominated by the principal investigator would have a conflict of interest because they presumably would know and would have worked with the principal investigator.

2005 

5. Stats: Taking charges of conflicting interest too far (June 4, 2005). You should always be aware of potential conflicts of interest. Sometimes researchers allow a financial incentive to influence their research and end up skewing  the data to achieve a particular outcome. More uncertain is the belief that researchers working in an area will try to obtain findings that encourage greater research funding in the area they work in. This might manifest itself in a tendency to exaggerate the importance of a particular disease and to overstate the number of people affected. One author commented that having an NIH grant is the biggest conflict of interest of all.

4. Stats: More on conflicts of interest (March 23, 2005). I need to write up something on my very incomplete page on Intellectual conflict of interest. A review in JAMA of the report, Complementary and Alternative Medicine in the United States, which I commented on in a January 24, 2005 weblog entry, has an interesting quote about conflict of interest.

2004 

3. Stats: Intellectual conflict of interest [Incomplete] (November 24, 2004). Here are some web pages that discuss the concept of an intellectual conflict of interest.

2. Stats: Conflict of interest (July 20, 2004). Does having a commercial interest in the results of a drug trial cause a problem for the people running the trial? If it does, then much of the research that we rely on could be flawed. A recent article in the British Medical Journal raises some serious concerns: Efficacy and safety of antidepressants for children and adolescents. Jureidini JN, Doecke CJ, Mansfield PR, Haby MM, Menkes DB, Tonkin AL. Bmj 2004: 328(7444); 879-83.

1. Stats: Conflict of Interest (February 25, 2004). The New York Review of Books has a extensive review written by Richard Horton of the book Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? by Sheldon Krimsky. The review has an extensive bibliography, and cites some good work about problems with the quality and conclusions of corporate sponsored research.

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Creative Commons License This work is licensed under a Creative Commons Attribution 3.0 United States License. This page was written by Steve Simon and was last modified on 2010-04-11.