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. You
can find outside resources at the bottom of
this page. Other entries about conflict of interest can be found in the
conflict of interest page at the
StATS website.
2009
- 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
- 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:
- 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].
- All Gifts Large and Small -
Toward an Understanding of the Ethics of Pharmaceutical Industry Gift-Giving
Description: This article notes that even gifts of negligible value can
influence behavior and recommends that arbitrary value limits for reporting
are inappropriate.
- Assessing faculty financial
relationships with industry: A case study 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.
- Association between competing
interests and authors' conclusions: epidemiological study of randomised
clinical trials published in the BMJ. 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.
- Association of funding and
conclusions in randomized drug trials: a reflection of treatment effect or
adverse events? Description: This article notes that industry funded
studies are more likely to recommend the experimental drug. This result apears
to be associated not with any particular finding of better efficacy or better
safety, but rather a biased interpretation of trial results.
- Association between industry
funding and statistically significant pro-industry findings in medical and
surgical randomized trials 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.
- Avoiding conflicts of interest
in drug research Description: Coming soon!
- Being a modern pharmaceutical
company: involves making information available on clinical trial programmes
Description: This article highlights the policy at GlaxoWellcome to
register information on all the clinical trials that it conducts.
- Beyond conflict of interest.
Transparency is the key [editorial] 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.
- Bias in analytic research
Description: Coming soon!
- 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].
- Blood lead levels, scientific
misconduct and the Needleman case. 3. A reply from Scarr and Ernhart
Description: Coming soon!
- 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].
- Conflict of interest and
cost-effectiveness analysis Description: This article reviews the
viewpoints for and against disclosing financial conflicts of interest. Then
the author summarizes a research publication of the influence of financial
support in studies of cost effectiveness.
- Conflict of interest and the
American Journal of Bioethics Description: Coming soon!
- Conflict of interest and the
physician-researcher Description: This article suggests that indirect
research support may undermine the investigator's role to serve first as an
advocate for his/her patient.
- Conflict of interest and the
public trust 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.
- 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].
- Conflict of interest in the
debate over calcium-channel antagonists 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.
- Does the type of competing
interest statement affect readers' perceptions of the credibility of research?
Randomised trial Excerpt: Financial relationships among industry and
academic institutions are diverse and common.1 These interests can influence
authors' conclusions2 and readers' perceptions of published studies.3 We
report the effects on reader perceptions of different statements of competing
interests for two manuscripts.
- 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.
- Journal Policies on Conflict of
Interest: If This Is the Therapy, What's the Disease? Description: This
article criticizes the policies that most journals have for reporting
conflicts of interest.
- Fear and loathing of pharmaceutical
statistics
- Operating the smokescreen
- Is academic medicine for sale?
- Cholesterol lowering trials in coronary
heart disease: frequency of citation and outcome
- Conflict-of-interest policies for
investigators in clinical trials
- Conflict of interest policies in science
and medical journals: editorial practices and author disclosures
- 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.
- Declaring financial competing interests:
survey of five general medical journals
- Deficits in psychologic and classroom
performance of children with elevated dentine lead levels
- Disclosure and Disinterest
- Disclosure policies for gifts from
industry to academic faculty
- Disclosure of Authors' Conflicts of
Interest: A Follow-up
- Does the type of competing interest
statement affect readers' perceptions of the credibility of research?
Randomised trial
- Economic incentives in clinical
investigation
- Editorials and Conflicts of Interest
- Efficacy and safety of antidepressants for
children and adolescents
- Environmental lead and children's
intelligence
- Ethics issues in academic-industry
relationships in the life sciences: the continuing debate
- Evaluation of conflict of interest in
economic analyses of new drugs used in oncology
- 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].
- Financial Associations of Authors
- Financial interest and its disclosure in
scientific publications
- Financial interests of authors in
scientific journals: a pilot study of 14 publications
- Financial Conflict-of-Interest Policies in
Clinical Research: Issues for Clinical Investigators
- Funding source, trial outcome and
reporting quality: are they related? Results of a pilot study
- Get-the-lead-out guru challenged
- 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].
- How can research ethics committees protect
patients better?
- 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.
- Influences on the Quality of Published
Drug Studies
- Institutions, Contracts, and Academic
Freedom
- Journal Policies on Conflict of Interest:
If this Is the Therapy, What's the Disease?
- Lung cancer and passive smoking. Turning
over the wrong stone
- National office of drug safety is needed,
experts say in JAMA
- New England Journal loosens its rules on
conflict of interest
- 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].
- Nonfinancial conflicts of interest in
research
- Of whistleblowers, investigators, and
judges
- On being a whistleblower: the Needleman
case
- Operating the smokescreen
- Participation of life-science faculty in
research relationships with industry
- Pharmaceutical industry sponsorship and
research outcome and quality: systematic review
- Policies on faculty conflicts of interest
at US universities
- Potential solutions to the problem of
conducting systematic reviews of new health technologies
- Print media coverage of research on
passive smoking
- Problem is greater than editorial
indicates
- The publication of sponsored symposiums in
medical journals
- The Quality of Drug Studies Published in
Symposium Proceedings
- Reanalysis of epidemiological evidence on
lung cancer and passive smoking
- Relationships between academic
institutions and industry in the life sciences--an industry survey
- Reference bias in reports of drug trials
- Relationships between authors of clinical
practice guidelines and the pharmaceutical industry
- Reply to Ernhart, Scarr, and Geneson
- A reply to Scarr and Ernhart
- Review of the quality of studies on the
economic effects of smoke-free policies on the hospitality industry
- 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].
- Salem comes to the National Institutes of
Health: notes from inside the crucible of scientific integrity
- Scientific journals and their authors'
financial interests: a pilot study
- Scope and impact of financial conflicts of
interest in biomedical research: a systematic review
- Source of funding and outcome of clinical
trials
- Sponsorship, Authorship and Accountability
- A Study of Manufacturer-Supported Trials
of Nonsteroidal Anti-inflammatory Drugs in the Treatment of Arthritis
- Systematic reviews and meta-analyses on
treatment of asthma: critical evaluation
- Tobacco Industry Efforts to Defeat the
Occupational Safety and Health Administration Indoor Air Quality Rule
- Tobacco industry research: collaboration,
not confrontation, is the best approach
- The uncertainty principle and
industry-sponsored research
- Uneasy Alliance - Clinical Investigators
and the Pharmaceutical Industry
- What scientists funded by the tobacco
industry believe about the hazards of cigarette smoking
- When commitments and interests conflict.
"There's probably no greater conflict of interest than an NIH grant"
- Why Review Articles on the Health Effects
of Passive Smoking Reach Different Conclusions
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.
2008
2007
- 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.
- 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.
- 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?
- 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.
- 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.
- 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
- 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
- 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.
- 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
- 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.
- 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
- Stats: Intellectual conflict of
interest [Incomplete] (November 24, 2004). Here are some web pages that
discuss the concept of an intellectual conflict of interest.
- 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.
- 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 Attribution 3.0 United States License. This page was written by
Steve Simon and was last modified on
2010-04-11.