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It was in October 1999 that a consensus conference under the joint
auspices of the Royal College of Physicians of Edinburgh, the Faculty of
Pharmaceutical Medicine and the ABPI called for the setting up of a
National Panel for Research Integrity (1). It was in the following year
the the editors of the BMJ, Lancet and Gut wrote about the UK's failure to
act on research misconduct (2). It was in 2001 that two distinguished
American commentators suggested that, based on the declaration following
the consensus conference and much that had happened since, the UK should
begin the hard, contentious but necessary work of framing their own rules
(3).
What has now happened? We learn from a news item (4) that the Academy of
Medical Sciences, charged with the respionsibility of taking a lead on
this issue, has made proposals so weak and ineffective that the reputation
of the Academy must now be under serious threat. Those of us who have
been responsible for taking a whole series of actions against doctors who
have fabricated data, exploited their patients, and hoodwinked their
sponsors (5), know only too well that fraudsters within the medical
profession will go to considerable lengths to cover up the evidence of
their misdemeanours but that vigilant monitoring and audit may, hopefully,
uncover their misdeeds. The comment of Professor Peter Lachmann (4) that
"the scientific enterprise simply wouldn't work if people felt the need to
check up on everything, and it would simply become corroded by suspicion
and mistrust" is alarming in its ineptitude and in its total unwillingness
to accept reality.
Just the opposite to what Lachmann says is what is now
needed: an acceptance of the need for all biomedical research to be
subjected to monitoring and audit so that it can be trusted. Corrosion has already set in because of the inability of to recognise the need for a corrective process to treat
that corrosion. Fortunately, the imminent introduction of the European
Commission Directive on clinical trials, affecting all research involving
human subjects, will to some extent supervene the archaic and outdated
views of the Academy of Medical Sciences. It can only be hoped that the
Academy will rethink its position in the light of the comments already
published (4) and incorporated in this letter, or that some other body,
more motivated to take appropriate action, will intervene.
Frank Wells
References:
1. Joint Consensus Conference on Misconduct in Biomedical Research
Statement. 28-29 October 1999.
www.rcpe.ac.uk/esd/consensus/misconduct_00.html
2. Farthing M, Horton R, Smith R. Research misconduct; Britain's failure to act. BMJ
2000;321:1485-86
3. Rennie D, Gunsalus CK. Regulations on scientific misconduct. In Fraud and Misconduct in
Biomedical Research, 3rd edition. London: BMJ Books, 2001.
4. Mayor S. Proposals for UK body to investigate research fraud "lack teeth". BMJ 2002;325:1382
5. Wells FO. Counteracting research misconduct. In Fraud and Misconduct in Biomedical Research,
3rd edition. London: BMJ Books, 2001.
Competing interests:
Non-executive director of MedicoLegal Investigations Ltd
Competing interests:
No competing interests
14 December 2002
Frank O Wells
Pharmaceutical physician (semi-retired)
Old Hadleigh, London Road, Capel St Mary, Ipswich, IP9 2JJ
A National Panel for Research Integrity
Sir,
It was in October 1999 that a consensus conference under the joint auspices of the Royal College of Physicians of Edinburgh, the Faculty of Pharmaceutical Medicine and the ABPI called for the setting up of a National Panel for Research Integrity (1). It was in the following year the the editors of the BMJ, Lancet and Gut wrote about the UK's failure to act on research misconduct (2). It was in 2001 that two distinguished American commentators suggested that, based on the declaration following the consensus conference and much that had happened since, the UK should begin the hard, contentious but necessary work of framing their own rules (3).
What has now happened? We learn from a news item (4) that the Academy of Medical Sciences, charged with the respionsibility of taking a lead on this issue, has made proposals so weak and ineffective that the reputation of the Academy must now be under serious threat. Those of us who have been responsible for taking a whole series of actions against doctors who have fabricated data, exploited their patients, and hoodwinked their sponsors (5), know only too well that fraudsters within the medical profession will go to considerable lengths to cover up the evidence of their misdemeanours but that vigilant monitoring and audit may, hopefully, uncover their misdeeds. The comment of Professor Peter Lachmann (4) that "the scientific enterprise simply wouldn't work if people felt the need to check up on everything, and it would simply become corroded by suspicion and mistrust" is alarming in its ineptitude and in its total unwillingness to accept reality.
Just the opposite to what Lachmann says is what is now needed: an acceptance of the need for all biomedical research to be subjected to monitoring and audit so that it can be trusted. Corrosion has already set in because of the inability of to recognise the need for a corrective process to treat that corrosion. Fortunately, the imminent introduction of the European Commission Directive on clinical trials, affecting all research involving human subjects, will to some extent supervene the archaic and outdated views of the Academy of Medical Sciences. It can only be hoped that the Academy will rethink its position in the light of the comments already published (4) and incorporated in this letter, or that some other body, more motivated to take appropriate action, will intervene.
Frank Wells
References:
1. Joint Consensus Conference on Misconduct in Biomedical Research Statement. 28-29 October 1999. www.rcpe.ac.uk/esd/consensus/misconduct_00.html
2. Farthing M, Horton R, Smith R. Research misconduct; Britain's failure to act. BMJ 2000;321:1485-86
3. Rennie D, Gunsalus CK. Regulations on scientific misconduct. In Fraud and Misconduct in Biomedical Research, 3rd edition. London: BMJ Books, 2001.
4. Mayor S. Proposals for UK body to investigate research fraud "lack teeth". BMJ 2002;325:1382
5. Wells FO. Counteracting research misconduct. In Fraud and Misconduct in Biomedical Research, 3rd edition. London: BMJ Books, 2001.
Competing interests: Non-executive director of MedicoLegal Investigations Ltd
Competing interests: No competing interests