conflict by lanyuehua

VIEWS: 2 PAGES: 37

									Conflict of interest: an
editor’s jaundiced view

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

•      ______ 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)
•    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.
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

								
To top