Transcript Conflict of interest: journals, guidelines, and societies

Conflict of interest: journals,
guidelines, and specialist
societies
Richard Smith
Editor, BMJ
Rome October 2001
Rome (you) and Scotland (me)
• The native Caledonians preserved in the Northern extremity
of the island their wild independence, for which they were
not less indebted to their poverty than to their valour. Their
incursions were frequently repelled and chastised, but their
country was never subdued. The masters of the fairest and
most wealthy climates of the globe turned with contempt
from gloomy hills assailed by the winter tempest, from lakes
concealed in blue mist, and from cold and lonely heaths over
which the deer of the forest were chased by a troop of naked
barbarians.
• Edward Gibbon
What I want to talk about
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What is conflict of interest?
How common is it?
Does it matter?
Conflict of interest and journals
Conflict of interest and guidelines
Conflict of interest and societies
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).
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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?
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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?
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______ A fee for speaking?
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______ A fee for organising education?
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______ Funds for research?
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______ Funds for a member of staff?
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______ 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.
• (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
How common are competing interests?
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75 articles
89 authors
69 (80%) responded
45 (63%) had financial conflicts of interest
• Only 2 of 70 articles disclosed
the conflicts of interest
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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
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.
• Reviews that acknowledge sponsorship by the
pharmaceutical or tobacco industry are more likely to
draw conclusions that are favourable to the industry.
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?
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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.
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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)
• The sponsored study with a relative risk of 1.5 has been reanalysed
several times, yielding lower relative risks; after this failed to
convince, a new reanalysis was sponsored by another company.
• One sponsored study finding an increased risk has not been published.
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Vandenbroucke JP, Helmerhorst FM, Frits R Rosendaal FR. Competing interests and controversy
about third generation oral contraceptives. BMJ 2000; 320: 381.
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’ perceptions of studies?
• 300 BMJ readers randomised to receive a study
with a competing interest statement declaring a
relationship with a pharmaceutical company or the
same study with no competing interest statement
• 46% response rate
• Readers rated the study with the competing
interest statement significantly lower on all of
five characteristics: interest, importance,
relevance, validity, and believability
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Unpublished study by Samena Chaudhuri and Richard Smith
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 (if any) 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?
Words on guidelines and
specialist societies
• Most guidelines produced by specialist societies are of
poor quality
• Of 431 guidelines produced by specialist societies only one
in seven gave information on who produced them, only
about a fifth did a search of evidence, and only a quarter
graded recommendations
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Grilli R, Magrini N, Penna A, Mura G, Liberati A. Practice guidelines developed by specialty
societies: the need for critical appraisal. Lancet 2000; 355: 103-6.
• In specialty guidelines for colon cancer screening
radiologists recommend barium enemas while
gastroenterologists recommend colonoscopy.
A cautionary tale 1
• Many trials suggest that thrombolytic
therapy may be harmful in acute stroke
• Despite that the American Heart Association
has recently recommended tPA as a Class I
(“definitely recommended”) intervention for
stroke in its Guidelines 2000.
A cautionary tale 2
• The AHA claims that it assembles ‘independent’
panels to make recommendations but will not
release conflict of interest statements signed by
panelists.
• Independent verification reveals that most of the
AHA’s expert stroke panelists have had ties to the
manufacturers of tPA
A cautionary tale 3
• Genentech, the US manufacturer of tPA,
contributed over $11 million to the AHA in
the decade prior to the AHA’s
recommendation.
• Is this all a coincidence? Even if it is, it
looks bad.
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A tale told to me by Jeanne Lenzer, medical investigative journalist
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
• 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