The Henshall Hearing: Adjournment of GMC Hearing AGAIN.

Monday, June 30, 2008

Adjournment of GMC Hearing AGAIN.

Paediatricians and Psychiatrists
Pitching a Tent Near GMC Manchester.
They would rather pitch a tent rather
than recognise the threat of Scientology.

This is of course the umpteenth adjournment by the GMC. We predict that the GMC will make a finding that there is a case to answer. This is because the GMC has to be seen to be reacting to publicity. The GMC admitted to a Article 6 Violation of Human Rights of the doctors earlier on in the hearing. The Sentinel misinterpretes the facts again. The statistics report from Professor Hutton was supportive of the doctors' work.

We agree with Penny Mellor's sentiments, the doctors might as well pitch a tent in Manchester. We also suggest that Penny Mellor advises the Royal College of Psychiatrists as well as the paediatricians that tents will be required. She and her cohorts at CCHR are due to subject a majority of them to revolving door GMC procedures.

Sentinel

HEARING AGAINST CNEP TRIAL DOCTORS SUSPENDED IN LIGHT OF PLEAS

09:40 - 28 June 2008

A long-running disciplinary hearing against three North Staffordshire doctors accused of serious professional misconduct has been adjourned for a week.

The interruption after almost a month of evidence is to allow a panel set up by the General Medical Council to consider legal pleas that the medics have no case to answer.

The charges facing paediatricians Drs David Southall, Andrew Spencer and Martin Samuels relate to the so-called CNEP experiments on babies carried out at the North Staffordshire Hospital during the early 1990s.

They follow complaints first made 13 years ago by Clayton parents Carl and Deborah Henshall who claim the research caused the death of one of their baby daughters and brain damage in another.

The Henshalls have already given several days of evidence that they did not give informed consent for the infants to be used in the trial.

The GMC's professional conduct committee has also taken testimony from other North Staffordshire families whose babies were in CNEP, a statistician on how the research was evaluated and a specialist in medical ethics.

Dr Southall who has retired from the University Hospital of North Staffordshire has already been struck off the medical register for an unrelated matter, but been reinstated pending his appeal. The other two still work there.

At the start of the Manchester hearing, the panel ruled out submissions on behalf of Drs Spencer and Samuels that the events happened so long ago that they would be deprived of a fair trial.

CNEP involved premature babies into negative pressure tanks to allow them to breathe more naturally than by using traditional ventilation.

The hearing is scheduled to end on July 11.

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About this website

The Henshall case revolves around the concerns raised by Carl and Deborah Henshall. Their concerns related to their perception of events at North Staffordshire NHS Trust in 1992.

Over many years, the Henshalls [ with the assistance of Penny Mellor] have relentlessly pursued Drs Southall, Samuels and Spencer of North Staffordshire NHS Trust. The Henshalls have used and abused the media to their own advantage on each occasion. They were also responsible for a vexatious complaint against Dr Keith Prowse of North Staffordshire NHS Trust.

The CNEP trial, challenged by the Henshalls was vindicted by the Nottingham Study

Over the years, the General Medical Council has spent large amounts of doctor's subscription funds assessing this [out of time] complaint. This has been done while sacrificing other worthy cases that deserves the GMC's attention for the public interest.

Up to date Reporting Directly From the Hearing

GENERAL MEDICAL COUNCIL

FITNESS TO PRACTISE PANEL

(applying the General Medical Council’s Preliminary ProceedingsCommitteeand Professional Conduct Committee (Procedure Rules) 1988)

On:

Tuesday, 13 May 2008

Held at:

St James’s Buildings

79 Oxford Street

Manchester M1 6FQ

Case of:

STEPHEN ANDREW SPENCER BM BS 1976 University of Nottingham
Registration No: 2305893

DAVID PATRICK SOUTHALL MRCS 1971 Royal College of Surgeons of England

Registration No: 1491739

MARTIN PHILIP SAMUELS MB BS 1981 University of London

Registration No: 2732178

(Day Two)

Panel Members:

Mr D Kyle (Chairman)

Mrs V Brickley

Mrs S Hollingworth

Dr T Okitikpi

Dr M Sheldon

Mr A Forrest (Legal Assessor)

--------------------------------------

MR M FORDE, Queen’s Counsel, instructed by RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Spencer.

MISS M O’ROURKE, Counsel, instructed by Hempsons, Solicitors, appeared on behalf of Dr Southall.

MR C FOSTER, Counsel, instructed by RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Samuels.

MS J SULLIVAN, Counsel, instructed by Eversheds, Solicitors, appeared on behalf of the General Medical Council and the Complainants, Mr and Mrs C Henshall.

As Charged by the GMC

Fitness to Practise Panel

Planned dates: 8 May to 11 July 2008

St James’s Building, 79 Oxford Street, Manchester, M1 6FQ

The Fitness to Practise Panel will meet at St James’s Building, 79 Oxford Street, Manchester, M1 6FQ to consider a case under the Professional Conduct Committee Rules of serious professional misconduct.

Name: Dr Martin Philip SAMUELS

GMC Reference Number: 2732178

Area of practice: Staffordshire

Name: Dr Stephen Andrew SPENCER

GMC Reference Number: 2305893

Area of practice: Staffordshire

Name: David Patrick SOUTHALL

GMC Reference Number: 1491739

Area of practice: Staffordshire

Dr Samuels

It is alleged that Dr Samuels was practising as a paediatrician at the Royal Brompton and North Staffordshire Hospitals and a trial was commenced in 1990 to determine the benefit or otherwise of continuous negative extrathoracic pressure (CNEP) in babies with respiratory failure (“the CNEP trial”). It is alleged that in his role as an administrator of the CNEP trial he failed to ensure that appropriate procedures were in place to obtain informed parental consent to the patients’ participation in the trial. It is further alleged that his actions in this regard were inappropriate, inadequate, not in the patients’ best interests and likely to bring the medical profession into disrepute.

Dr Spencer

It is alleged that Dr Spencer was practising as a Consultant Paediatrician at North Staffordshire Hospital, Stoke-on-Trent and on 29 November 1989, he applied to the Ethics Committee of the North Staffordshire Royal Infirmary (“the Ethics Committee”) for approval of a trial entitled “A randomised controlled trial of continuous sub-atmospheric (negative) extra thoracic pressure (CNEP) in neonatal respiratory failure.” (“the CNEP trial”). It is alleged that his actions in this regard were inappropriate, inadequate, not in the patients’ best interests and likely to bring the medical profession into disrepute.

It is further alleged that on 14 December 1992 Patient A was born by Caesarian section at the North Staffordshire Maternity Hospital and that following her birth, Patient A was entered into the CNEP trial. It is alleged that during his involvement in Patient A’s care,

he failed to ensure that the appropriate steps were taken to treat Patient A’s hypoxia until 12:30pm on 15 December 1992 and that he failed to ensure that appropriate and regular blood pressure checks were undertaken and/or recorded in her notes. It is alleged that his actions in this regard were inappropriate, inadequate, not in the patients’ best interests and likely to bring the medical profession into disrepute.

Dr Southall

It is alleged that Dr Southall was practising as a Consultant Paediatrician at the Royal Brompton and North Staffordshire Hospitals and that on 29 November 1989, he applied to the Ethics Committee of the North Staffordshire Royal Infirmary (“the Ethics Committee”) for approval of a trial entitled “A randomised controlled trial of continuous sub-atmospheric (negative) extra thoracic pressure (CNEP) in neonatal respiratory failure.” (“the CNEP trial”). It is alleged that the application inaccurately described the procedures that would be applied to each patient and/or, the number of patients that would be required for the trial. The design of the trial was such that it did not sufficiently minimise the possibility of bias. It is alleged that his actions in this regard were inappropriate, inadequate, not in the patients’ best interests and likely to bring the medical profession into disrepute

In accordance with Rule 41(2) of the General Medical Council (Fitness to Practise) Rules 2004, the Panel may decide to exclude the public from the proceedings or any part of the proceedings, where they consider that the circumstances of the case outweigh the public interest in holding the hearing in public.

These charges were altered mid hearing following a statistics report confirming the high standard of practise by the doctors.

This was the final charge sheet

8 May 2008 a Fitness to Practise Panel will consider the case of:

A Dr Stephen Andrew SPENCER
Registration number: 2305893

Registered address: Neo-Natal Unit (Maternity), University Hospital
North Staffordshire, City General Hospital, Newcastle Rd, Stoke-on-Trent,
Staffordshire, ST4 6QG
(pages 3 to 6)

And

B Dr David Patrick SOUTHALL

Registration number: 1491739
Registered address: Academic Department of Paediatrics, City General
Hospital, Stoke On Trent, Staffordshire, ST4 6QG
(pages 7 to 9)

And

C Dr Martin Philip SAMUELS

Registration number: 2732178
Registered address: The Old Vicarage, Buxton Road, Buxton, Derbyshire, SK17
0NZ
(pages 10 to 11)

These cases will be considered by a Fitness to Practise Panel applying the
General Medical Council’s Preliminary Proceedings Committee and Professional
Conduct Committee (Procedure Rules) 1988.

The hearing will commence at 9.30 am at:

General Medical Council
5th Floor
St James’s Buildings
79 Oxford Street
Manchester
M1 6FQ

Type of case: New case of serious professional misconduct.

The case is expected to last 46 days

Panel Members: Mr D Kyle (Lay) Chairman
Mrs V Brickley (Lay)
Mrs S Hollingworth (Lay)
Dr T Okitikpi (Layl)
Dr M Sheldon (Medical)

Legal Assessor: Mr A Forrest

If you require any further information or assistance, please call
Adjudication Management Section on 0161 923 6591 or visit the GMC website
www.gmc-uk.org.

If an emergency arises out of hours that may prevent your attendance at the
required time please call 0161 923 6513 and leave a message. We will not be
able to call you back at the time, but it will enable us to act on your
message as soon as the office opens the next working day.

A The Panel will inquire into the following allegation against Dr Stephen
Andrew Spencer, BM BS 1976 University of Nottingham.

“That being registered under the Medical Act;

1. At all material times you were practising as a Consultant Paediatrician
at North Staffordshire Hospital, Stoke-on-Trent;

2. On 29 November 1989, you applied to the Ethics Committee of the North
Staffordshire Royal Infirmary (“the Ethics Committee”) for approval of a
trial entitled “A randomised controlled trial of continuous sub-atmospheric
(negative) extra thoracic pressure (CNEP) in neonatal respiratory failure.”
(“the CNEP trial”);

3. The application inaccurately described,

a. the procedures that would be applied to each Patient,

b. the number of patients that would be required for the trial;
Withdrawn by the GMC

4. The design of the trial was such that it did not sufficiently minimise
the possibility of bias; Withdrawn by the GMC

5. The trial received Ethics Committee approval on 10 January 1990;

6. In or around February 1990, at Queen Charlottes Hospital, a trial patient
was found to have experienced neck trauma,

a. This was an adverse event which should have been reported to the Ethics
Committees of both Queen Charlottes and North Staffordshire Hospitals,

b. You failed to report the matter to the North Staffordshire Ethics
Committee,

7. On 15 May 1990, two changes were made to the scoring system,

a. These were changes to the Trial Protocol which should have been reported
to the Ethics Committee,

b. You failed to report the changes to the Ethics Committee;

8. In or around July or August 1991, artificial surfactant was introduced as
a treatment option for patients in the trial,

a. This was a change to the Trial Protocol which should have been reported
to the Ethics Committee,
b. You failed to report the matter to the Ethics Committee;

9. On 11 September 1991, the exclusion criteria were amended to include
patients were born following prolonged ruptured membranes, providing this
was of not more than 7 days' duration,

a. This was an amendment to the Trial Protocol which should have been
reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

10. By the time that 100 patients from North Staffordshire had participated
in the trial it was apparent that substantially more patients from North
Staffordshire would be required to participate, Withdrawn by the GMC

a. This was a change to the Trial Protocol which should have been reported
to the Ethics Committee, Withdrawn by the GMC

b. You failed to report the matter to the Ethics Committee;
Withdrawn by the GMC

11. In your role as a responsible investigator in the conduct of the CNEP
trial you failed to ensure that appropriate procedures were in place to
obtain informed parental consent to the patients’ participation in the CNEP
trial, in particular,

a. You inappropriately delegated the task of taking consent to too many
different medical and nursing staff,

b. You failed to provide adequate training to those taking consent for the
trial,

c. You misrepresented within the parental information leaflet that the
technique had been shown to be safe,

d. You failed to ensure that every parent had a copy of the parental
information leaflet;

12. In your role as a responsible investigator in the conduct of the CNEP
trial,
a. You used a scoring system that was not validated,
Withdrawn by the GMC

b. You failed to ensure that the scores were allocated correctly,

c. You failed to ensure that the scores were calculated correctly,
Withdrawn by the GMC
d. You failed to ensure that there was an appropriate method of scoring,

e. You thereby failed to produce valid results from the trial;
Withdrawn by the GMC

13. You co-authored a paper entitled “Continuous Negative Extrathoracic
Pressure in Neonatal Respiratory Failure” published in Paediatrics on 6
December 1996 (“the Paediatrics Paper”), Withdrawn by the GMC

a. The abstract states “The overall outcome score showed an overall
significant benefit for CNEP”, Withdrawn by the GMC

b. This statement should not have been made in view of the defects in the
scoring system referred to in Head 12 above;
Withdrawn by the GMC

14. On 14 December 1992 Patient 6 was born by Caesarean section at the North
Staffordshire Maternity Hospital;

15. Following her birth, Patient 6 was entered into the CNEP trial;

16. Between the hours of 00:03 on 15 December 1992 and 12:30 hours on 15
December 1992;

a. Patient 6’s PO2 level was recorded to be low at levels varying between
4.5 to 4.7,

b. Patient 6’s oxygen saturation level was recorded to be normal at levels
varying between 94% to 99%,

c. Patient 6’s pH level was recorded at levels between 7.23 and 7.28
suggesting that she was acidotic,

d. Patient 6’s PCO2 level was raised at levels varying between 6.3 to 7.4,

e. This combination of results suggested that the oxygen saturation monitor
was faulty,

f. This combination of results suggested that Patient 6 was hypoxic,

g. You failed to ensure that the appropriate steps were taken to treat
Patient 6’s hypoxia until 12:30pm on 15 December 1992;

17. During your involvement in Patient 6’s care, you failed to ensure that
appropriate and regular blood pressure checks were undertaken and/or
recorded in her notes;
18. On 22 December 1992, an ultrasound scan taken of Patient 6’s skull was
reported to show “increased density on the left. Suspicious of clot attached
to the choroid plexus and associated with mild lateral ventricular
dilatation”;

a. You failed to inform Patient 6’s parents of this abnormality,

19. On 29 December 1992, a further ultrasound scan taken of Patient 6’s
skull was reported to show “mild symmetrical dilatation of the lateral
ventricles consistent with haemorrhage, although no clot is definitely
identified within the ventricular system",

a. You failed to inform Patient 6’s parents of this abnormality;

20. On 7 January 1993, Patient 6 was discharged from the Neonatal Unit,

a. You failed to arrange for Patient 6 to have a further ultrasound scan
prior to her discharge from the Neonatal Unit;

21. Your actions as outlined above were,

a. inappropriate,

b. inadequate,

c. not in the patients’ best interests,

d. likely to bring the medical profession into disrepute;

And that in relation to the facts alleged you have been guilty of serious
professional misconduct.”

B The Panel will inquire into the following allegation against Dr David
Patrick Southall, MRCS 1971 Royal College of Surgeons of England.

“That being registered under the Medical Act;

1. At all material times you were practising as a Consultant Paediatrician
at the Royal Brompton and North Staffordshire Hospitals;

2. On 29 November 1989, you applied to the Ethics Committee of the North
Staffordshire Royal Infirmary (“the Ethics Committee”) for approval of a
trial entitled “A randomised controlled trial of continuous sub-atmospheric
(negative) extra thoracic pressure (CNEP) in neonatal respiratory failure.”
(“the CNEP trial”);

3. The application inaccurately described

a. the procedures that would be applied to each Patient 6nd/or,

b. the number of patients that would be required for the trial;
Withdrawn by the GMC

4. The design of the trial was such that it did not sufficiently minimise
the
possibility of bias; Withdrawn by the GMC

5. The trial received Ethics Committee approval on 10 January 1990;

6. In or around February 1990, at Queen Charlottes Hospital, a trial patient
was found to have experienced neck trauma

a. This was an adverse event which should have been reported to the Ethics
Committees of both Queen Charlottes and North Staffordshire Hospitals,

b. You failed to report the matter to the Ethics Committee of North
Staffordshire Hospital;

7. On 15 May 1990, two changes were made to the scoring system,

a. These were changes to the Trial Protocol which should have been reported
to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

8. In or around July or August 1991, artificial surfactant was introduced as
a treatment option for patients in the trial

a. This was a change to the Trial Protocol which should have been
reported to the Ethics Committee,
b. You failed to report the matter to the Ethics Committee;

9. On 11 September 1991, the exclusion criteria were amended to include
patients who were born following prolonged ruptured membranes, providing
this was of not more than 7 days duration

a. This was an amendment to the Trial Protocol which should have been
reported to the Ethics Committee,

b. You failed to report the matter to the Ethics Committee;

10. By the time that 100 patients from North Staffordshire had participated
in the trial, it was apparent that substantially more patients from North
Staffordshire would be required to participate Withdrawn by the GMC

a. This was a change to the Trial Protocol which should have been reported
to the Ethics Committee, Withdrawn by the GMC

b. You failed to report the matter to the Ethics Committee;
Withdrawn by the GMC

11. In your role as a responsible investigator in the conduct of the CNEP
trial you failed to ensure that appropriate procedures were in place to
obtain informed parental consent to the patients’ participation in the CNEP
trial, in particular

a. You inappropriately delegated the task of taking consent to too many
different medical and nursing staff,

b. You failed to provide adequate training to those taking consent for the
trial,

c. You misrepresented within the parental information leaflet that the
technique had been shown to be safe,

d. You failed to ensure that every parent had a copy of the parental
information leaflet;

12. In your role as a responsible investigator in the conduct of the CNEP
trial

a. You used a scoring system that was not validated,
Withdrawn by the GMC

b. You failed to ensure that the scores were allocated correctly,

c. You failed to ensure that the scores were calculated correctly,
Withdrawn by the GMC
d. You failed to ensure that there was an appropriate method of scoring,

e. You thereby failed to produce valid results from the trial;
Withdrawn by the GMC

13. You co-authored a paper entitled “Continuous Negative Extrathoracic
Pressure in Neonatal Respiratory Failure” published in Paediatrics on
6 December 1996 (“the Paediatrics Paper”) Withdrawn by the GMC

a. The abstract states “The overall outcome score showed an overall
significant benefit for CNEP”, Withdrawn by the GMC

b. This statement should not have been made in view of the defects in the
scoring system referred to in Head 12 above;
Withdrawn by the GMC

14. Your actions as outlined above were

a. inappropriate,

b. inadequate,

c. not in the patients’ best interests,

d. likely to bring the medical profession into disrepute;

And that in relation to the facts alleged you have been guilty of serious
professional misconduct.”

C The Panel will inquire into the following allegation against Dr Martin
Philip Samuels, MB BS 1981 University of London.

“That being registered under the Medical Act;

1. At all material times you were practising as a paediatrician at the Royal
Brompton and North Staffordshire Hospitals;

2. In 1990 a trial was commenced to determine the benefit or otherwise of
continuous negative extrathoracic pressure (CNEP) in babies with respiratory
failure (“the CNEP trial”);

3. In your role as an administrator of the CNEP trial you failed to ensure
that appropriate procedures were in place to obtain informed parental
consent to the patients’ participation in the CNEP trial, in particular,

a. You inappropriately delegated the task of taking consent to too many
different medical and nursing staff,

b. You failed to provide adequate training to those taking consent for the
trial,

c. You misrepresented within the parental information leaflet that the
technique had been shown to be safe,

d. You failed to ensure that every parent had a copy of the parental
information leaflet;

4. In your role as an administrator of the CNEP trial,

a. You used a scoring system that was not validated,
Withdrawn by the GMC

b. You failed to ensure that the scores were allocated correctly,

c. You failed to ensure that the scores were calculated correctly,
Withdrawn by the GMC

d. You failed to ensure that there was an appropriate method of scoring,

e. You thereby failed to produce valid results from the trial;
Withdrawn by the GMC

5. You co-authored a paper entitled “Continuous Negative Extrathoracic
Pressure in Neonatal Respiratory Failure” published in Paediatrics on 6
December 1996 (“the Paediatrics Paper”), Withdrawn by the GMC

a. The abstract states “The overall outcome score showed an overall
significant benefit for CNEP”, Withdrawn by the GMC

b. This statement should not have been made in view of the defects in the
scoring system referred to in Head 4 above;
Withdrawn by the GMC

6. Your actions as outlined above were,

a. inappropriate,

b. inadequate,

c. not in the patients’ best interests,

d. likely to bring the medical profession into disrepute;

And that in relation to the facts alleged you have been guilty of serious
professional misconduct.”