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.
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.
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