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We write to express our appreciation of, and thanks to, Professor Rod
Griffiths for publishing (1, 2) his perspectives on the events triggered
by allegations that the trial of Continuous Negative Extrathoracic
Pressure (CNEP) undertaken in neonates in Stoke on Trent was so flawed
that it amounted to serious professional misconduct. Everything we have
come to know about this saga has made it clear that many of the
allegations of misconduct had little to do with the CNEP trial and a lot
to do with a determined campaign to destroy doctors who had been involved
in child protection work, particularly David Southall and Martin Samuels.
As Professor Griffiths reports, once Ministers had agreed that an enquiry
into the CNEP trial should take place, campaigners came out of the
woodwork and demanded that the terms of reference of the enquiry be
extended to investigate the child protection work done by these two
paediatricians – in Professor Griffiths’ apt language, to top up the
poisoned chalice that he had been handed.
We agree wholeheartedly with Professor Griffiths’ conclusion that “if
you have to drink from a poison chalice, better to do it in full public
view.” We can also agree with him that, had a body capable of
investigating complaints about research in public been in existence eight
years ago, it might well “have come to similar conclusions” to his panel
about the need for a more effective system of research governance. Given
Professor Griffiths’ views now on the CNEP trial (2), we are confident
that he agrees with us that a thorough, public investigation would have
been highly unlikely to have found fault with the way the CNEP trial was
conducted.
However, as we have made clear in our commentary in the Lancet (3),
allegations of forged consent forms made behind closed doors continue to
hang over the heads of 34 doctors who were providing neonatal care in
Stoke on Trent during the early 1990s. No evidence to support these
allegations has yet been made public. If consent forms were forged that is
a scandal; if they were not then the allegations were false and highly
derogatory and damaging (4).
Although we believe that the Department of Health is largely to blame
for the failure to ensure natural, transparent justice in this affair,
matters would not have got so completely out of hand after the
Department’s report appeared had some of the paediatricians most critical
of the clinicians in Stoke been required to defend their opinions in
public then and there. This observation applies particularly to Professor
Terry Stacey, one of the three members of Professor Griffiths’ enquiry
team (who was appointed to direct the Central Office for Research Ethics
Committees soon after this report was completed), and to Richard
Nicholson, Editor of the Bulletin of Medical Ethics, who has declared
confidently that CNEP was used in research without parental consent (5).
The clinicians in Stoke should be assumed to be innocent of this charge
unless a proper investigation, conducted in public, reveals otherwise.
Iain Chalmers and Edmund Hey
References
1 Griffiths R. On drinking from a poisoned chalice. bmj.com, 1 April
2006.
2 Griffiths R. CNEP and research governance. Lancet 2006;367:1037–8.
3 Hey E, Chalmers I. Are any of the criticisms of the CNEP trial true?
Lancet 2006;367:1032–3.
4 Hey E. The 1996 Continuous Negative Extrathoracic Pressure (CNEP)
trial: were parents’ allegations of research fraud fraudulent? (in press) [Subsequently published in Pediatrics 2006;117;2244-2246]
5 Nicholson R. Editorial. Bulletin of Medical Ethics May 2003, p 1.
Competing interests:
None declared
Editor’s note:
This response was submitted in April 2006, but technical problems relating to the fact that the article which it was responding to had been posted as a webextra article meant that the response couldn't be displayed. See editor's footnote to that article for further explanation - http://www.bmj.com/cgi/content/full/337/oct31_2/a2347
This article has now been republished as a stand alone article, making it possible to post rapid responses to it.
An appreciation of Professor Griffiths' identification of a poisoned chalice
We write to express our appreciation of, and thanks to, Professor Rod
Griffiths for publishing (1, 2) his perspectives on the events triggered
by allegations that the trial of Continuous Negative Extrathoracic
Pressure (CNEP) undertaken in neonates in Stoke on Trent was so flawed
that it amounted to serious professional misconduct. Everything we have
come to know about this saga has made it clear that many of the
allegations of misconduct had little to do with the CNEP trial and a lot
to do with a determined campaign to destroy doctors who had been involved
in child protection work, particularly David Southall and Martin Samuels.
As Professor Griffiths reports, once Ministers had agreed that an enquiry
into the CNEP trial should take place, campaigners came out of the
woodwork and demanded that the terms of reference of the enquiry be
extended to investigate the child protection work done by these two
paediatricians – in Professor Griffiths’ apt language, to top up the
poisoned chalice that he had been handed.
We agree wholeheartedly with Professor Griffiths’ conclusion that “if
you have to drink from a poison chalice, better to do it in full public
view.” We can also agree with him that, had a body capable of
investigating complaints about research in public been in existence eight
years ago, it might well “have come to similar conclusions” to his panel
about the need for a more effective system of research governance. Given
Professor Griffiths’ views now on the CNEP trial (2), we are confident
that he agrees with us that a thorough, public investigation would have
been highly unlikely to have found fault with the way the CNEP trial was
conducted.
However, as we have made clear in our commentary in the Lancet (3),
allegations of forged consent forms made behind closed doors continue to
hang over the heads of 34 doctors who were providing neonatal care in
Stoke on Trent during the early 1990s. No evidence to support these
allegations has yet been made public. If consent forms were forged that is
a scandal; if they were not then the allegations were false and highly
derogatory and damaging (4).
Although we believe that the Department of Health is largely to blame
for the failure to ensure natural, transparent justice in this affair,
matters would not have got so completely out of hand after the
Department’s report appeared had some of the paediatricians most critical
of the clinicians in Stoke been required to defend their opinions in
public then and there. This observation applies particularly to Professor
Terry Stacey, one of the three members of Professor Griffiths’ enquiry
team (who was appointed to direct the Central Office for Research Ethics
Committees soon after this report was completed), and to Richard
Nicholson, Editor of the Bulletin of Medical Ethics, who has declared
confidently that CNEP was used in research without parental consent (5).
The clinicians in Stoke should be assumed to be innocent of this charge
unless a proper investigation, conducted in public, reveals otherwise.
Iain Chalmers and Edmund Hey
References
1 Griffiths R. On drinking from a poisoned chalice. bmj.com, 1 April
2006.
2 Griffiths R. CNEP and research governance. Lancet 2006;367:1037–8.
3 Hey E, Chalmers I. Are any of the criticisms of the CNEP trial true?
Lancet 2006;367:1032–3.
4 Hey E. The 1996 Continuous Negative Extrathoracic Pressure (CNEP)
trial: were parents’ allegations of research fraud fraudulent? (in press) [Subsequently published in Pediatrics 2006;117;2244-2246]
5 Nicholson R. Editorial. Bulletin of Medical Ethics May 2003, p 1.
Competing interests:
None declared
Editor’s note:
This response was submitted in April 2006, but technical problems relating to the fact that the article which it was responding to had been posted as a webextra article meant that the response couldn't be displayed. See editor's footnote to that article for further explanation - http://www.bmj.com/cgi/content/full/337/oct31_2/a2347
This article has now been republished as a stand alone article, making it possible to post rapid responses to it.
Competing interests: No competing interests