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Two streamlined articles today

1. The Metro

2. Controversial medic hearing resumes.

Salient features of the this week's events can be read here.

Most of the antics by the GMC was omitted by the media including the recent supportive statistics report obtained by the GMC.

3. DOCTORS ARGUE THEY CAN'T HAVE FAIR TRIAL
Source - Sentinel

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DAVE BLACKHURST
DAVE.BLACKHURST@THESENTINEL.CO.UK

09:40 - 14 May 2008

Two North Staffordshire doctors facing disciplinary charges over their involvement in a breathing study on sick babies say it happened so long ago they will be robbed of a fair trail.

But a third medic, Dr David Southall, intends to, "defend the allegations one by one and show them as hollow and baseless", the General Medical Council heard yesterday.

Along with fellow paediatricians, doctors Andrew Spencer and Martin Samuels, he is before the GMC's fitness to practice panel in Manchester to answer complaints by Clayton couple Carl and Deborah Henshall.

They claim one baby, Stacey, died after two days and another, Sofie, now 15, has brain damage because they were placed into low pressure CNEP tanks as part of a research programme in the early 1990s.

More than 100 babies were subject to the programme, to see if they could breath without ventilators in their wind pipes.

The GMC opened the two month hearing by dramatically withdrawing a number of charges relating to statistical parts of the study and clearing an academic paper the doctors published on it.

But Dr Spencer is still facing charges over his care of Sofie soon after her birth at the then North Staffordshire Hospital in December 1992 and the way he took consent from parents.

Dr Southall faces concerns both over taking consent and his application for ethical approval of the research.

And Dr Samuels faces claims that, as research administrator, he failed to ensure appropriate procedures were in place to obtain informed consent.

For Dr Southall, who has just resigned from his job at the hospital, Mary O'Rourke said: "He believes there has been an inordinate and inexcusable delay in this case caused by the GMC and the complainants and that will stop him having a fair trial.

"But he still wants to defeat all allegations one by one and he wants me to cross-examine the complainants."

Martin Ford QC, for Dr Spencer, described the case as being as old as any to come before the panel with one charge expecting witnesses to remember what happened at three minutes past midnight on December 15, 1992.

He said: "This delay is not the doctors' responsibility. A lot of witnesses will be extremely defensive about their role in the 1990s. There is a real fear they will not be judged by 1990s' standards, but by those of 2008.

"These matters have been twice investigated already and 90 per cent of parents recall giving consent. There is no suggestion in the charges that any child came to harm from CNEP, whatever the Henshalls say.

"In the study there was a higher death and disability rate among the babies undergoing CNEP than those having normal ventilation. But the doctors argue that with such sick infants it was not significant

Henshall Hearing Continues

NHS - Behind the Headlines has an interesting update of this week's antics at the GMC.

It is said that the charges have been streamlined and half the original ones have been dropped. The hearing will continue next week.

The Henshall Case - the FACTS behind the Myth

Extract from Response to a Report of a review of the research framework in North Staffordshire Hospital NHS Trust (The Griffiths Report), released by the NHS Executive on May 8th 2000 Dated 23rd September 2000

4.3 Origin of the inquiry.

Comment

"The Review began because there were complaints about the conduct of research trials in North Staffordshire". [Part One]

Response

Mr and Mrs X, one set of parents making complaints, have made very public their views that 1) they were not told that CNEP was being offered to their children as part of a randomised controlled study, 2) they believe that CNEP caused brain injury to their child and 3) they had not signed consent, alleging that it was forged.

It is evident that parents have to cope with extreme stress when their child is critically ill. Evidence was also presented to the panel outlining that during this stressful period some parents enrolled into another published study had no recollection of having signed a consent form. It is therefore possible that Mr and Mrs X genuinely believed that they had not signed a consent form. However, some of the following information does not support the claims of this family.

During the recovery of their daughter from neonatal respiratory failure, Mr and Mrs X received a letter and completed a questionnaire on maternal child bonding. It is not possible for them to have failed to understand that their daughter had been entered into a controlled study of CNEP. A letter was sent to them beginning " "Dear [NAME OF PARENT(S)],
You will remember that shortly after [NAME] was born you kindly agreed to enroll him/her into our study comparing negative pressure respiratory support with standard treatment. As part of this study we have devised a questionnaire which attempts to compare the effect of these two methods of treatment on the way you were able to relate to your baby."

Mrs X replied to this questionnaire and indicated that in her opinion CNEP was more effective than standard treatment.

Mr and Mrs X stated in a letter in October 1999 to the British Medical Association the following: "..this group of parents who have raised concerns about the clinical implications of CNEP, have no connection whatsoever with Mrs Penny Mellor or Mr Morgan who are apparently campaigning on child abuse issues". The Guardian newspaper on 13th October 1999 published a correction in response to a letter from Mr and Mrs X concerning an article in the Guardian of 11th October reviewing the campaign against my child protection work. The correction was written as follows: they "would like to make it clear they have not criticized Southall's work in child protection and have no connection with those who have campaigned against Southall's work on Munchausen Syndrome by Proxy".

However, evidence for the existence of a connection is as follows:

· Mr and Mrs X's story first appeared in an article by a reporter called Brian Morgan in the Sunday Independent on 11 May 1997. The same reporter Mr Brian Morgan is quoted as saying in the Mail on Sunday on April 5th 1998 the following: "his and the mothers' aim is to see Southall struck off the medical register, his work discredited and a public inquiry instigated".
· In a letter to my employer on 3rd June 1997 and given to me, Mr and Mrs X wrote the following: "Why then would he slowly suffocate my child with his machine and lie in order to cover up what he had done? How many other babies like… have been subjected wrongly to this torture and when will he realize that it is the case of the pot calling the kettle black and that he has no rights criticizing Mums for how they look after their children when he experiments on hundreds at a time in the name of science even with knowledge of adverse effects. Have the courts seen the photographs of the tiny babies who were strangled by the neck seal on his gentle form of ventilation? ".
· In April / May 1997, Mr Brian Morgan, and Mr and Mrs X wrote similar letters to the Editor of ‘Pediatrics’ criticising my work in North Staffordshire
· In June 1997, Mr and Mrs X wrote to Keele University, Mr Brian Morgan's letter to Pediatrics was mentioned, the response of the editor to Mr Brian Morgan was quoted and Mr Brian Morgan was described as a friend.
· In March 1999, Mr Brian Morgan, Mrs Penny Mellor and Mrs X all wrote electronic responses to an article in the BMJ about my humanitarian aid work in Afghanistan [33]
· A person calling herself Penny posted on the internet on 25 April 1999 details of the alleged problems with Mrs X's consent form:
"Re:Negative Pressure
The previous respondent has been very circumspect with what they said, it is not an allegation but a fact. Mrs X's (one of the mothers taking action) consent form that she was supposed to have signed two hours after the birth of her daughter, had the name of her child on the form…..except that her and her husband had not even chosen a name for their child at that point. So who signed the form? Who entered her child's name? GMC responses please… Also all you British lawyers and QC's whom I have heard look at this site and know who I am will you finally have the ***** to help? Just in case any of you are in any doubt, The Mr and Mrs X's were due for CVS according to an inside source. What would have happened then? Accused of putting her on a bit of research machinery in order to damage her……are there any lengths these people will not go to….?".
· A person calling himself Brian Morgan posted the following on the MAMA website on 28th October 1999:
o The CNEP scandal emerged because the X family in Staffordshire were told by a doctor looking at medical notes belonging to their brain damaged daughter CHILD"S NAME that she had been in a study, as if they already knew knew about this.
o They didn't, and this led to them getting hold of further documents, one of which purported to be a research consent form signed by Mrs X, with CHILD"S name on it, spelled incorrectly as NAME.
o The problem for the hospital is that the parents did not decide on a name for several days and NAME was not even thought of initially.
o The other problem is that the form needed to be signed between between 2 and 4 hours after birth - during these hours Mrs X was in recovery from anaesthesia following a C section.
o Her signature on the form is perfectly formed - not the sedated scrawl you might expect from somebody still out for the count.
o Hardly informed consent. And as Dr NAME the medical director admitted on TV it was not possible anyway.
o The hospital has still to explain how her signature appears on this form.
o This is the theory though - Mrs X got her own notes from the hospital and (I can confirm this) there are a number of consent forms for other procedures she underwent - you can see clearly as a bell where someone has tried to alter the forms and then tried to correct the alterations - but most interestingly - one consent form Mrs X knows she signed a good while after CHILD"S NAME was born is missing. Work it out.
o This scenario is duplicated to some degree or another in other cases I have researched.
o The X family did a major amount of work on their case and on a number of other cases that came forward on the back of articles in their local newspaper.
o This first of all resulted in a General Medical Council investigation being set up, and then the Griffiths Inquiry set up by the NHS Executive in the West Midlands on the insistence of the then health minister Baroness Hayman.
o Then when this was underway Penny Mellor took her concerns about false allegations of child abuse and other very serious allegations about child protection work of doctors at North Staffs and elsewhere to the same team.
o A number of other investigations have been set up, in all around 6.
o I haven't done more than scratch the surface of what my own research and the X family's research into CNEP has shown.

Professor Griffiths and the Panel made clear their acceptance of Mr and Mrs X's criticisms. In the Sentinel newspaper (local to Stoke), it was stated on 10 May 2000: “The dogged determination of Mr and Mrs X drew high praise from Prof Rod Griffiths as he delivered his stinging report on child health research in North Staffordshire. Professor Griffiths … said: ‘we were impressed by their attitude’…”

In a recent local newspaper article Mr and Mrs X signalled their intention to claim damages from the North Staffordshire Hospital for many millions of pounds"

The rest of the document can be downloaded here.

Henshalls " Memory Lapse" [Complaint Against Dr Keith Prowse]

Of course, no one suffered a memory lapse that seems to have occurred many years after 1992. Our question is this, is the " memory lapse" defence a desperate attempt to mitigate the accusations the Henshalls have made in all the media outlets for many many years - ie that the consent forms were forged. Of course, they were never forged. The article and defence shows that no one believes this Memory Lapse story listed as a " get out clause" "once caught red handed". Infact the GMC Committee at the time did not believe it either. If it indeed a lie, then we should seriously question the level of NHS funds and doctors subscriptions invested in relatives of dubious credibility. If these accusations of forgery were ever made in a statement of truth..... it is interesting what Penny Mellor would say.

After the Prowse case, the GMC should have questioned the credibility of the Henshalls. They didn't question this.

From the BBC Article.

"Parents would have been reluctant to accept the advice of doctors they believed to be guilty of forgery.

The allegation of forgery was "entirely false", the committee said.

Lawyers acting for Mrs Henshall complained that the finding implied that Mrs Henshall had lied.

They said it "coloured" the committee's ruling to the extent that the whole decision should be overturned.

But on Thursday, Mr Justice Keith refused Mrs Henshall permission to challenge the decision.

He held that the finding did not reflect on Mrs Henshall's honesty or credibility.

The committee, which had heard evidence that she might have suffered from a memory lapse because she signed under the after-effects of anaesthetic, was simply saying that she had indeed signed the consent form.

The judge also rejected a plea that the reference to the falsity of the forgery claim should be deleted from the record of the committee's decision because it could prejudice a medical negligence damages claim being brought against the hospital on behalf of her disabled child.

Mr Justice Keith said the forgery issue had no bearing on the pending damages claim, which concerned the quality of the research and care provided by the hospital.

The Discredited Griffiths Inquiry

This is described by Hey and Chalmers here.
Their summary findings are listed below

Summary points

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We believe that almost every statement made about the design, conduct, and reporting of the neonatal continuous negative extrathoracic pressure (CNEP) trial in the Griffiths report was ill informed, misguided, or factually wrong. Errors include:

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A false assertion that the trial's design had not been subjected to external peer review

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A failure to understand the trial's statistical design, as evinced by their erroneous belief that Professor Southall was single handedly responsible for its size and shape

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A failure to recognise the expertise of the nurses involved in the study

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A false statement that some of the consent forms could not be found

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A false statement that it was not possible to be sure who had completed some of these forms

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A false statement that there was no way of checking that consent had been obtained properly

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An inaccurate statement that the process of consent was not managed consistently and that no system of management or documentation was in place to prove that it was

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A false assertion that parents were not given clear opportunities to withdraw their child from the study at any time

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A failure to take sufficiently into account evidence showing that parental recall of events in the newborn period can be fallible

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An overreliance on the evidence of the small group of parents who asked to testify to the panel at the expense of contemporaneous evidence from a questionnaire sent to all parents and returned by 79% at discharge

Desperate GMC Seeks Delay

The BBC reports a delay in the case relating to Southall, Samuels and Spencer. The Guardian summarises the case but both leave out the fact that the Nottingham Study vindicated the CNEP trials and the Department of Health Inquiry by Professor Griffiths was discredited.

The reason for the delays requested by the GMC is because the GMC is in serious trouble. This trouble will be reported later.