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.

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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

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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

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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.

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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

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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)

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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)

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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