Transcript Fraud in medical research

Fraud in medical
research
Richard Smith
Editor, BMJ
September 2001
What I want to talk about
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Why fraud matters
Britain’s 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)
Why fraud matters
• It’s like child abuse: we didn’t
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
Britain’s most dramatic
case of fraud
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
August 1996: a major
breakthrough
• Achieved by Malcolm Pearce, a
senior lecturer in at St George’s
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.
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 George’s.
• The same issue contained a
randomised controlled trial also by
Malcolm Pearce -- and others.
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 hadn’t
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 hadn’t done much.
What had happened?
• A young doctor at St George=s 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.
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.
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
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
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
What is fraud?
• We need a full taxonomy
• Better we need codes of good
research practice--and we now
have several
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?
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?
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
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
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
Why does scientific fraud
happen?
• Why wouldn’t 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.
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
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
COPE’s 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)
COPE’s 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)
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