Curs 2 MCS Misconduct Research 3.ppt

7/27/2019 Curs 2 MCS Misconduct Research 3.ppt

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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

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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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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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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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Curs 2 MCS Misconduct Research 3.ppt