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Fraud in medical research

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It corrupts the scientific record and leads to false conclusions ... A front page story in the Daily Mail exposed the two papers as fraudulent. ... – PowerPoint PPT presentation

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Title: Fraud in medical research


1
Fraud in medical research
  • Richard Smith
  • Editor, BMJ
  • September 2001

2
What I want to talk about
  • Why fraud matters
  • Britains most dramatic case of fraud
  • What is fraud?
  • How common is it?
  • Why does it happen?
  • What does a country need to respond?
  • A comment on COPE (Committee on Publication
    Ethics)

3
Why fraud matters
  • Its like child abuse we didnt recognise it,
    now we see alot
  • It undermines public trust in medical research
    and doctors
  • It corrupts the scientific record and leads to
    false conclusions
  • Most countries do not have good systems of either
    treatment or prevention

4
Britains most dramatic case of fraud
5
August 1996 a major breakthrough
  • Worldwide media coverage of doctors in London
    reimplanting an ectopic pregnancy and a baby
    being born
  • Doctors had been trying to do this for a century.
    It was a huge achievement

6
August 1996 a major breakthrough
  • Achieved by Malcolm Pearce, a senior lecturer in
    at St Georges Hospital Medical School in London
  • A world famous expert on ultrasonography in
    obstetrics
  • A story from a paper in the British Journal of
    Obstetrics and Gyneacology. Pearce was an
    assistant editor.

7
August 1996 a major breakthrough
  • A second author on the case report was Geoffrey
    Chamberlain, editor of the journal, president of
    the Royal College of Obstetricians and
    Gynaecologists, and professor and head of
    department at St Georges.
  • The same issue contained a randomised controlled
    trial also by Malcolm Pearce -- and others.

8
Autumn 1996 both papers are fraudulent
  • A front page story in the Daily Mail exposed the
    two papers as fraudulent.
  • It had a full length picture of Geoffrey
    Chamberlain saying that he hadnt known that the
    work was fraudulent despite his name being on the
    paper.
  • Chamberlain said it was common within medicine
    for people to have their name on papers when they
    hadnt done much.

9
What had happened?
  • A young doctor at St Georges Hospital Medical
    School had raised questions about the two papers.
  • An investigation was promptly started and showed
  • The patient did not exist.
  • The patients supposedly in the randomised trial
    could not be found
  • Among studies investigated back to 1989 - three
    others fraudulent, two of them in the BMJ.

10
What had happened?
  • All the papers were retracted. Questions about
    ones before that.
  • Pearce was fired and subsequently struck off by
    the General Medical Council
  • Chamberlain retired or resigned from all his
    positions, a terrible end to a distinguished
    career.
  • His crime was gift authorship, which was normal
    at the beginning of his career, scandalous by the
    end.

11
What is fraud?
  • The Americans have argued for years over a
    definition
  • The Europeans have tended to take a broad view
    and not attempt a specific, operational definition

12
What is fraud?
  • Fabrification Invention of data or cases
  • Falsification Wilful distortion of data
  • Ignoring outliers?
  • Not admitting that some data are missing.
  • Post hoc analyses that are not admitted?
  • Not including data on side effects in a clinical
    trial

13
What is fraud?
  • Plagiarism Copying of data or papers
  • But by how much?
  • Stealing ideas?
  • Redundant publication
  • Gift authorship.
  • Not attributing other authors.
  • Not publishing research
  • Not disclosing a conflict of interest

14
What is fraud?
  • We need a full taxonomy
  • Better we need codes of good research
    practice--and we now have several

15
How common is fraud?
  • Obviously depends on how fraud is defined?
  • How does serious fraud relate to minor fraud?
  • Are they quite separate?
  • Does minor progress to serious?

16
How common is fraud?
  • How many of you know of a case?
  • In how many of those cases was there a proper
    investigation, punishment if necessary, and a
    correction of the scientific record?

17
Study by Stephen Lock
  • Asked 80 researchers who were friends, mostly
    British. Not a random sample.
  • 100 response rate.
  • Over half knew of cases
  • Over half the dubious results had been published
    - only 6 retractions - all vague and not using
    that term

18
How common is fraud?
  • US congressional inquiry heard of over 700 cases
  • The British General Medical Council has dealt
    with over 30 cases
  • Committee on Publication Ethics has discussed
    over a 100 cases

19
How common is fraud?
  • Redundant publication occurs in around a fifth of
    published papers
  • About a fifth of authors of studies in medical
    journals have done little or nothing
  • Most authors of studies in medical journals have
    conflicts of interest, yet they are declared in
    less than 1 of cases

20
Why does scientific fraud happen?
  • Why wouldnt it happen? It happens in all other
    human activities.
  • Pressure to publish.
  • Inadequate training. Not taught good practice.
    Indeed, sometimes taught the opposite.
  • Does sloppy behaviour spill over to fraud?
  • You can get away with it. The system works on
    trust.

21
What does a country need to respond to research
fraud?
  • A recognition of the problem by the medical
    community and its leaders
  • An independent body to lead with investigations,
    prevention, teaching and research
  • An agreement on what fraud is
  • Protection for whistleblowers
  • A body to investigate allegations
  • A fair system for reaching judgements
  • A code of good practice
  • Systems for teaching good practice

22
Committee on Publication Ethics (COPE)
  • Founded in 1997 as a response to growing anxiety
    about the integrity of authors submitting studies
    to medical journals.
  • Founded by British medical editors--including
    those of the BMJ, Gut, and Lancet

23
COPEs five aims
  • Advise on cases brought by editors
  • Publish an annual report describing those cases.
    Three published (www.publicationethics.org.uk)
  • Produce guidance on good practice
  • Encourage research
  • Offer teaching and training
  • (Shame the British establishment into mounting a
    proper response)

24
COPEs first 103 cases
  • In 80 cases there was evidence of misconduct.
  • Several cases have been referred to employers and
    to regulatory bodies
  • Problems were
  • undeclared redundant publication or submission
    (29),
  • disputes over authorship (18)
  • falsification (15)
  • failure to obtain informed consent (11)
  • performing unethical research (11)
  • failure to gain approval from an ethics committee
    (10)

25
Conclusion
  • Research misconduct is problem
  • Most countries have not developed a coherent
    response to the problem
  • They need to in order to avoid a collapse in
    public trust in medical research
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