Transcript Conflict of interest: an editor’s jaundiced view Richard Smith Editor, BMJ

Conflict of interest: an
editor’s jaundiced view
Richard Smith
Editor, BMJ
March 2003
www.bmj.com/talks
What I want to talk about
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What is conflict of interest?
How common is it?
Does it matter?
How are readers affected by
conflict of interest statements
• Conflict of interest and journals
• How to respond?
What is conflict of interest?
• Conflict of interest is a set of
conditions in which professional
judgement concerning a
primary interest (such as
patients' welfare or the validity
of research) tends to be unduly
influenced by a secondary
interest (such as financial gain).
• Thompson DF. Understanding financial conflicts of
interest. N Engl J Med 1993; 329: 573-576
What is conflict of interest?
• Conflict of interest is a
condition not a behaviour.
Do you have a conflict of
interest?
• 1. Have you in the past five years accepted
the following from an organisation that
may in any way gain or lose financially
from the results of your study or the
conclusions of your review, editorial, or
letter:
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______ Reimbursement for attending a
symposium?
______ A fee for speaking?
______ A fee for organising education?
______ Funds for research?
______ Funds for a member of staff?
______ Fees for consulting?
Do you have a conflict of
interest?
• 2. Have you in the past five years been
employed by an organisation that may in
any way gain or lose financially from the
results of your study or the conclusions of
your review, editorial, or letter?
• 3. Do you hold any stocks or shares in an
organisation that may in any way gain or
lose financially from the results of your
study or the conclusions of your review,
editorial, or letter?
• 4. Do you have any other competing
financial interests? If so, please specify.
Competing interest
statement
• Competing interests: RS has been
reimbursed by Shangri La
Products, the manufacturer of
elysium, for attending several
conferences; TD has been paid by
Shangri La Products for running
educational programmes and has
her research registrar paid for by
the company; JS has shares in the
company.
Do you have a conflict of
interest?
• We are restricting ourselves to asking
directly about competing financial
interests, but you might want to
disclose another sort of competing
interest that would embarrass you if it
became generally known after
publication. The following list gives
some examples.
• (a) A close relationship with, or a strong
antipathy to, a person whose interests
may be affected by publication of your
paper.
Do you have a conflict of
interest?
• (b) An academic link or rivalry with
somebody whose interests may be
affected by publication of your paper.
• (c) Membership of a political party or
special interest group whose interests
may be affected by publication of your
paper.
• (d) A deep personal or religious
conviction that may have affected what
you wrote and that readers should be
aware of when reading your paper.
Competing interest statement
• Competing interest: The BMJ hardly ever
publishes animal research. This is not
because we are against animal research but
rather because we favour research that may
have results that are directly applicable for
clinicians and those making public policy.
While doing a degree in experimental
pathology in 1973 I implanted stem cell
leukaemias into rats. I wrote this editorial a
few days after our pet rabbit was killed by a
fox. Her death upset me much more than I
ever expected.
• Statement for an editorial by Richard Smith, BMJ
editor, to an editorial on animal research
Conflicts of interest of
editors
• Nearly 20 years after asking
authors to declare conflicts of
interest we’ve declared those of
editors
• Editorial board
• Executive team
• BMJ Publishing Group board
Two questions
• 1. Should we ask people to
declare the relevant amounts in
financial conflicts of interest?
• Could there be a difference between being
given a ham sandwich and flown to New
York on Concorde and put up at the Plaza?
• 2 Should we require people to
declare non-financial conflicts
of interest?
How common are
competing interests?
• A quarter of US researchers have
received pharmaceutical funding
• Half have received “research related
gifts”
• An analysis of 789 articles from major
medical journals found that a third of
the lead authors had financial interests
in their research—patents, shares, or
payments for being on advisory boards
or working as a director
• Bekelman JE, Li Y, Gross CP. Scope and impact of
financial conflicts of interest in biomedical research. A
systematic review. JAMA 2003; 289: 454-65.
How common are competing
interests?
• 75 pieces giving views on calcium
channel blockers
• 89 authors
• 69 (80%) responded
• 45 (63%) had financial conflicts of
interest
• Only 2 of 70 articles disclosed
the conflicts of interest
• Stelfox HT, Chua G, O'Rourke K, Detsky AS. Conflict
of interest in the debate over calcium channel
antagonists. N Engl J Med 1998; 338: 101-105
Do authors declare
conflicts of interest?
• 3642 articles in the five leading
general medical journals (Annals
of Internal Medicine, BMJ, Lancet,
JAMA, and the New England
Journal of Medicine)
• Only 52 (1.4%) declared authors'
conflicts of interest
• Hussain A, Smith R. Declaring financial competing
interests: survey of five general medical journals.
BMJ 2001;323:263-4.
Do authors declare
conflicts of interest?
• The journals now have a policy of
requiring authors of randomised trials
funded by industry to declare
• The role of the sponsor in the study
• Who controlled the decision on
publication.
• A study of trials in the same five
journals showed that only the Annals
of Internal Medicine had ever
published such a statement
Why don’t authors declare
conflicts of interest?
• Some journals don’t require
disclosure
• The culture is one of not
disclosing
• Authors think that it’s somehow
“naughty”
• Authors are confident that they
are not affected by conflicts of
interest
Does conflict of interest
matter?
• Financial benefit makes doctors more
likely to refer patients for tests,
operations, or hospital admission, or to
ask that drugs be stocked by a hospital
pharmacy.
• Original papers published in journal
supplements sponsored by
pharmaceutical companies are inferior
to those published in the parent journal
• Rochon PA, Gurwitz JH, Cheung M, Hayes JA, Chalmers
TC. Evaluating the quality of articles published in journal
supplements compared with the quality of those
published in the parent journal. JAMA 1994; 272: 108-13.
Does conflict of interest
matter?
• 11 studies compared the outcome of
studies sponsored by industry and those
not so sponsored
• In every study those that were
sponsored were more likely to have a
finding favourable to industry
• When the results were pooled the
sponsored studies were almost four
times more likely to find results
favourable to industry
• Bekelman JE, Li Y, Gross CP. Scope and impact of
financial conflicts of interest in biomedical research. A
systematic review. JAMA 2003; 289: 454-65.
Does conflict of interest
matter?
• Is there a relationship between
whether authors are supportive
of the use of calcium channel
antagonists and whether they
have a financial relationship
with the manufacturers of the
drugs?
• Stelfox HT, Chua G, O'Rourke K, Detsky AS. Conflict
of interest in the debate over calcium channel
antagonists. N Engl J Med 1998; 338: 101-105
Does conflict of interest matter?
• 106 reviews, with 37% concluding that
passive smoking was not harmful and the
rest that it was.
• Multiple regression analysis controlling for
article quality, peer review status, article
topic, and year of publication found that the
only factor associated with the review's
conclusion was whether the author was
affiliated with the tobacco industry.
• Only 23% of reviews disclosed the sources
of funding for research.
• Barnes DE, Bero LA. Why review articles on the health effects
of passive smoking reach different conclusions. JAMA 1998;
279: 1566-1570
Does conflict of interest matter?:
third generation contraceptive pills
• At the end of 1998 three major studies
without sponsoring from the industry
found a higher risk of venous thrombosis
for third generation contraceptives;
three sponsored studies did not.
• To date, of nine studies without
sponsoring, one study found no difference
and the other eight found relative risks
from 1.5 to 4.0 (summary relative risk
2.4); four sponsored studies found
relative risks between 0.8 and 1.5
(summary relative risk 1.1)
Journals and conflict of
interest
• Conflict of interest is common
among authors
• Most journals have long had
policies that conflicts of
interest should be declared
• But mostly they are not
• Yet conflicts of interest seem to
have a strong effect on results
and how they are interpreted
How do conflict of interest
statements affect readers?
• 300 BMJ readers randomised to receive a
study on impact of pain from herpes
zoster on patients’ daily functioning with
• One group received the study with a
competing interest statement declaring
that they were employees of the
company and owned shares
• One group the same study with no
competing interest statement
• Asked to rate study for interest,
importance, relevance, validity, and
believability
How do conflict of interest
statements affect readers?
• 52% response rate
• Readers rated the study with the
competing interest statement
significantly lower on all of five
characteristics: interest, importance,
relevance, validity, and believability
• Chaudhry S, Schroter S, Smith R, Morris J.
Does declaration of competing interests affect
reader perceptions? A randomised trial. BMJ
2002; 325: 1391-2.
How do conflict of interest
statements affect readers?
• A further 150 readers sent the
short report with a statement that
one of the authors was a recipient
of funding for studentships and
research grants from the company
• No difference from the group sent
the paper with no competing
interest
How do conflict of interest
statements affect readers?
• Paper on the use of problem lists in letters
between hospital doctors and general
practitioners
• 150 no competing interest declared
• 150 a statement that one of the authors
was an employee of the company making
the software and potentially owned stock/
or holds stock options within the company
• 150 a statement that one of the authors is
a recipient of funding for studentships and
research grants from a company making
medical management software
How do conflict of interest
statements affect readers?
• 66% response rate
• No differences between groups
• Schroter S, Chaudhry S, Smith R, Morris J,
Barratt H
Conflict of interest within
journals
• Drug company sponsored
supplements have been shown to be
of inferior quality--but many journals
publish them. They are a major
source of income
• Some journals exist simply to publish
studies funded by pharmaceutical
companies
• Many journals depend heavily on
advertising: does this influence their
decisions on what to publish?
Conflict of interest within
journals
• Some journals publish advertising next
to related articles? Does this influence
what they publish?
• Some journals make millions of dollars
from reprints of articles--mostly of
randomised trials funded by
pharmaceutical companies
• With the big five journals around three
quarters of trials are funded by
pharmaceutical companies (30% for
BMJ)
Conflict of interest within
journals
• Acceptance of a particular study may
be accompanied by a reprint order of
more than a million dollars. It’s not
difficult to tell which studies might
produce such an order. Does this
influence the decision on which
studies to publish?
• Few journals publish the competing
interests of their editors, editorial
board, and management team and
board
Conflict of interest within journals
• Many specialist societies depend
financially on their journals
• This probably influences decisions on how
journals behave--over supplements,
advertising, pricing, and making material
available for free
• Almost no specialist societies have allowed
their journals to place their studies (often
funded with public money) on Pubmed
Central, but isn’t Pubmed Central good for
science and medicine and aren’t the
societies supposed to be about science
and medicine?
How to respond to conflict
of interest?
• “Disclosure is almost a panacea.”
John Bailar, professor of statistics,
University of Chicago
• Disclosure by authors, reviewers,
editors, editorial boards,
management committees,
presidents of societies
• “What isn’t transparent is assumed
to be biased, incompetent, or
corrupt.”
How to respond to conflict of
interest?
• “If in doubt, disclose.”
• Sometimes the conflict will be so strong
that it will forbid participation
• The danger of trying to eradicate
conflict of interest is that it may
encourage deception
• “The only person who doesn’t have a
vested interest in a subject is somebody
who knows nothing about it”
• “The only people who don’t have
personality disorders are those who
don’t have personalities.”
Conclusions
• Concern about conflict of interest
is not just political correctness
• Conflict of interest has an
important impact on the
information reaching health
professionals and the public and on
patient care
• Conflict of interest is very common
in medicine
Conclusions
• Conflicts of interest statement seem to
have an influence on readers’s
perceptions of studies
• Most conflicts of interest in medicine
are not disclosed
• Yet disclosure should be the main
response to conflict of interest
• We in health care need to do a better
job of managing conflict of interest
• This talk is available on www.bmj.com