Conflict of interest: an editor

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Conflict of interest an editors jaundiced view

• Richard Smith
• Editor, BMJ
• March 2003
• www.bmj.com/talks

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What I want to talk about

• 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?

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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

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What is conflict of interest?

• Conflict of interest is a condition not a
  behaviour.

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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
• ______ 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?

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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.

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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.

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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.

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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.

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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

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Conflicts of interest of editors

• Nearly 20 years after asking authors to declare
  conflicts of interest weve declared those of
  editors
• Editorial board
• Executive team
• BMJ Publishing Group board

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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?

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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
  researchpatents, 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.

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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

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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 2001323263-4.

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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

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Why dont authors declare conflicts of interest?

• Some journals dont require disclosure
• The culture is one of not disclosing
• Authors think that its somehow naughty
• Authors are confident that they are not affected
  by conflicts of interest

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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.

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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.

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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

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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

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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.
• Vandenbroucke JP, Helmerhorst FM, Frits R
  Rosendaal FR. Competing interests and controversy
  about third generation oral contraceptives. BMJ
  2000 320 381.

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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

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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

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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.

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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

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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

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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

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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?

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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)

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Conflict of interest within journals

• Acceptance of a particular study may be
  accompanied by a reprint order of more than a
  million dollars. Its 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

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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 isnt
  Pubmed Central good for science and medicine and
  arent the societies supposed to be about science
  and medicine?

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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 isnt transparent is assumed to be biased,
  incompetent, or corrupt.

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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 doesnt have a vested
  interest in a subject is somebody who knows
  nothing about it
• The only people who dont have personality
  disorders are those who dont have personalities.

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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

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Conclusions

• Conflicts of interest statement seem to have an
  influence on readerss 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