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Research misconductand biomedical journals
Richard SmithEditor, BMJ
www.bmj.com/talks
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What I want to talk about Why research misconduct matters
Some of medicines s most dramatic cases
What is research misconduct? How common is it?
Conflict of interest as a case study
Why does misconduct happen?
What does a country need to do torespond?
A comment on COPE (Committee on
Publication Ethics)
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Why research misconductmatters
Its like child abuse: we didnt
recognise it, now we see a lot
It undermines public trust in medicalresearch and health workers
It corrupts the scientific record and
leads to false conclusions
Most countries do not have good
systems of either treatment or
prevention
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William Summerlin from the
Sloan-Kettering, New York, 1974 Claimed to have transplanted human
corneas into rabbits
Faked transplantation experiments inwhite mice by blackening patches of
their skin with a pen
His misconduct was long ignored
Eventually attributed to a mental
health problem
A form of scientific denial
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Vijay Soman, Yale,
exposed 1980 A diabetologist and the author of 12 papers
where data were either missing or
fraudulent--all eventually retracted
A paper co-authored with Philip Felig, a
senior researcher, was stolen from another
author when Felig was sent a paper to
review and passed it on to Soman
Felig had to resign Senior figures putting their names on papers
which eventually turn to be fraudulent is a
recurrent problem
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John Darsee, department of
cardiology, Harvard, 1981 Observed falsifying data
His boss, Eugene Braunwald decided that this
misconduct was an isolated incident and so
did not fire him
A few months later it became clear that results
he had obtained in a multicentre study were
very different from those of the others
An investigation going showed that many ofhis more than a 100 studies were fraudulent
Again many of the studies included
distinguished authors
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Robert Slutsky, cardiological
radiologist, University of California Published 137 papers between 1978 and
1985--sometimes one every 10 days
A reviewer raised anxieties about some of
Slutskys work, illustrating how peer
review sometimes can pick up on fraud
An investigation decided that 12 of
Slutskys studies were definitely fraudulent
and 49 questionable
Many were retracted, although journals
declined to retract the studies
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Congressional hearings into
scientific misconduct Problems of scientifc misconduct are
rareand the product of psychopathic
behaviour originating in temporarily
deranged minds President of the NationalAcademy of Sciences
One reason for the persistence of this
type of problem is the reluctance of peoplehigh in the science field to take these
matters very seriously. Al Gore, chairman of thehearing
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Britains most dramaticcase of fraud
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August 1996: a majorbreakthrough
Worldwide media coverage of
doctors in London reimplanting
an ectopic pregnancy and ababy being born
Doctors had been trying to dothis for a century. It was a huge
achievement
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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.
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August 1996: a majorbreakthrough
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 arandomised controlled trial also by
Malcolm Pearce -- and others.
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Autumn 1996: bothpapers are fraudulent
A front page story in the Daily Mail
exposed the two papers as fraudulent.
It had a full length picture of GeoffreyChamberlain saying that he hadnt
known that the work was fraudulent
despite his name being on the paper.
Chamberlain said it was common withinmedicine for people to have their name
on papers when they hadnt done much.
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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.
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Britains slowest case?
Banerjee was awarded a Master of
Surgery degree by the University of
London for work that included the
fraudulent work--still not retracted
December 2000. Banerjee found guilty of
serious professional misconduct for
falsifying data and suspended
September 2002. Banerjee found guilty of
serious professional misconduct for
financial fraud and struck off
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Britains slowest case?
March 2001. Tim Peters, the professor
who supervised Banerjee, was found
guilty of serious professional misconduct
for failing to take action over the falsified
research
The GMC hearings were hampered by
notebooks being selectively shredded
by Kings,the medical school
Authorities at Kings conducted an inquiry
in 1991 but did not inform the GMC or Gut
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Does medicine
have a culture
that turns ablind eye to
researchmisconduct?
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What is researchmisconduct?
The Americans have argued for
years over a definition
The Europeans have tended to
take a broad view and not
attempt a specific, operationaldefinition
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US Commission on
Research Integrity (1996)
Research misconduct is significant
misbehaviour that improperly appropriates
the intellectual property or contributions of
others, that intentionally impedes theprogress of research, or that risks
corrupting the scientific record or
compromising the integrity of scientific
practices. Such behaviours are unethicaland unacceptable in proposing,
conducting, or reporting research, or in
reviewing the proposals or research
reports of others.
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Definition of research
misconduct proposed by aBritish consensus panel
(1999)
"Behaviour by a researcher,
intentional or not, that falls
short of good ethical andscientific standards."
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A preliminary taxonomy of researchmisconduct (ranked by seriousness) I Fabrication: invention of data or
cases
Falsification: wilful distortion of data Plagiarism: copying of ideas, data or
words without attribution
Failing to get consent from an ethics
committee for research
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A preliminary taxonomy of researchmisconduct (ranked by seriousness) II Not admitting that some data are
missing
Ignoring outliers without declaring it Not including data on side effects in a
clinical trial
Conducting research in humans without
informed consent or without justifyingwhy consent was not obtained from an
ethics committee
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A preliminary taxonomy of researchmisconduct (ranked by seriousness) III Publication of post hoc analyses
without declaration that they were
post hoc Gift authorship
Not attributing other authors
Redundant publication
Not disclosing a conflict of interest
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A preliminary taxonomy of researchmisconduct (ranked by seriousness) IV
Not attempting to publish completed
research Failure to do an adequate search of
existing research before beginning
new research
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What is fraud? We need a full taxonomy
Better we need codes of good
research practice--and we now
have several
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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?
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What is the relation of minor to
serious research misconduct?
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How common isresearch misconduct?
Redundant publication occurs in
around a fifth of published papers
About a fifth of authors of studies inmedical journals have done little or
nothing
Most authors of studies in medical
journals have conflicts of interest,yet they are declared in less than 5%
of cases
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Conflict of interest: acase study in poor
performance withinbiomedicine
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How common are competinginterests? 75 articles
89 authors
69 (80%) responded
45 (63%) had financial conflicts of interest
Only 2 of 70 articlesdisclosed the conflicts ofinterest
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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Why dont authors declareconflicts of interest?
Some journals dont require
disclosure
The culture is one of notdisclosing
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 interestmatter?
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.
Reviews that acknowledge sponsorship by the
pharmaceutical or tobacco industry are more
likely to draw conclusions that are favourable
to the industry.
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Does conflict of interestmatter?
Is there a relationship between whether
authors are supportive of the use ofcalcium 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 interestmatter?
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 yearof 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 contraceptivepills
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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Why does scientific fraudhappen?
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 tofraud?
You can get away with it. The system
works on trust.
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What does a country need torespond to research misconduct? A recognition of the problem by the medical
community and its leaders
An independent body to lead with
investigations, prevention, teaching andresearch
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
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Committee on PublicationEthics (COPE) Founded in 1997 as a response
to growing anxiety about the
integrity of authors submittingstudies to medical journals.
Founded by British medicaleditors--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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The same
probably goes
for physics--andyoure even
slower than us,wow
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