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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 Download Dr Southall's Document Here Situation Summary By NHS Exposed: Dr David Southall and Dr Martin Samuels have been subject to sundry complaints by a dysfunctional patient group led by ex felon Penny Mellor. All complaints against both doctors at the GMC have been solely from this group of patients / relatives. The accusations have often been flamboyant, colourful and bizzare. The allegations have had no basis in science. Each allegations no matter how bizarre has had to be defended at great expense to the tax payer, the defence unions and the health service. All NHS Inquiries and investigations have found no fault in the work of these two doctors. Both doctors face the GMC again on th 6th May 2008 in the Henshall case. Both Deborah and Carl Henshall have been supported by Penny Mellor and were infamous for making the complaint against Dr Keith Prowse. Dr Keith Prowse was cleared of any wrong doing following their vexatious complaint. We came across this interesting document written in the year 2000 by Dr David Southall who was then Professor of Paediatrics. Dr Southall dissects the evidence to the much criticised Griffiths Inquiry. We would urge you to read this document (see below). The media has had a field day courtesy of Penny Mellor's imagination and her soundbites. In the meantime, North Staffordshire NHS Trust at the time was said to have spent £750,000 on investigations that were ultimately pointless. As most people will be aware, the GMC has sanctioned Dr David Southall following the case of Ms M. It is also interesting to note that neither North Staffordshire NHS Trust nor the independent inquiries upheld the concerns raised by both Ms M and the Henshalls. The General Medical Council currently functions to scapegoat these two doctors to persaude the public that they are performing their function as a regulator following the Shipman Inquiry. As you will all note, the GMC have the wrong doctors in their clutches this time. The case of these two doctors should serve to remind others in the medical profession that they are not protected from patient groups who harass, perhaps for the sake of compensation. They are not protected from the catastrophic impact of a vexatious complaint at the GMC. These complaints now have to be disclosed to 5 years' worth of employers and even if the doctor is cleared, this would cause total assasination of their career. These two doctors have fought for more than 10 years, defending themselves against bizarre and baseless allegations. The harassment by these campaigners with a vendetta has not been recognised by the GMC, which still refuses to have a vexatious complaints policy. It should be noted that Penny Mellor has complained about the previous editor of NHS Exposed and caused the loss of her job. The Guardian featured an article called Climate of Fear detailing PACA's (Professionals Against Child Abuse) motion of no confidence in the General Medical Council. The GMC argues that three out of more than 600 since 2004 that led to disciplinary panels involved paediatricians accused over child protection issues. Mr Finlay Scott cleverly conceals how many complaints instigated by Penny Mellor have been taken up and investigated before being dropped by the GMC. A Freedom of Information Act Request to the GMC for this information was denied. Penny Mellor has attempted to silence us at NHS Exposed for featuring the truth about the anti-Southall campaign, her view appearing to be that the media should have one side of the tale and the doctor's side shall not have the oxygen of publicity. Dr Pal was subsequently cleared by the GMC but not without substantial robust defences against bizarre allegations that took almost 5 months to defend resulting in phenomenally high levels of paperwork. Defamatory and bizarre allegations were disclosed by the GMC to the Trust and locum agency thereby having a rebound effect on her employability. The relatives have spoken to the media, we believe it is time for us to hear the doctor's side of the story. One observation that is made from David Southall's writings is that he is methodical and does everything according to protocol. The allegations against both him and Dr Martin Samuels have been false and without basis. This document can be downloaded in Word format. We hope that the audience is able to balance the evidence to make their own decision about these two doctors. 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 By David P Southall OBE, MD, FRCP, FRCPCH Dated 23rd September 2000 Introduction I have written this response as the Principal Investigator of the research projects discussed in the Griffiths' Report following many visits to review the original data held by the North Staffordshire Hospital NHS Trust and freely made available to me. I wish to emphasise the time scale of the studies (for the neonatal study 1989-1993). The project on premature infants was undertaken between 7 and 11 years ago when research governance in general was much less rigorous than now. This response is only possible because most of the documentation remains available. I acknowledge the difficulties for the Panel in coping with this time scale. I must also make it clear that I am writing this as an individual and that the contents of this report are my responsibility and mine alone. I have attempted to ensure that all of the facts presented here are true and encompass the whole picture. They have not been selected or limited to create a misleading impression of what happened. Any opinions in this report are also my own. I would also wish to make it clear that I understand the difficulties for my employer (the North Staffordshire Hospital NHS Trust) with respect to dealing with the very well organised campaign designed to discredit all of my work and thereby bring to a halt the child protection activities that I have been undertaking for the last 15 years. In writing this document I am addressing a situation in which children
have died or are living lives affected by disability. The parents of children
who have suffered in this way have a terrible burden and I do not wish
to make this worse. The aim of our research was to reduce death and disability
and relieve the suffering of prematurely born infants. When this study
started there was a very high incidence of death and severe disability
in such babies, particularly those born more than 10 weeks before their
due time. National statistics for 1990-92 [at the time the introduction
of surfactant was just beginning Summary Contrary to written or implied criticism in the Panel’s report on research in children at the N. Staffordshire Hospital: • the two studies being examined (a randomized controlled trial of Continuous Negative Extrathoracic Pressure (CNEP) in neonatal respiratory failure and measurements of the effects of airway hypoxia in infants) were peer-reviewed • the neonatal CNEP study for ethical reasons employed a scoring system to facilitate a sequential study design. There was external input, peer review and stress testing of the score. • there was an effective management system and good documentation for both studies. • the nursing input to the neonatal project was experienced and professional The appointed clinical nurse specialist collected comprehensive data, filed it carefully, prepared high quality manuals for clinical staff and a booklet for parents. • the study team included a Chartered Statistician. He was closely involved in developing the protocol and in monitoring the sequential analysis in the neonatal project. • consent was obtained from a parent of all infants prior to their randomization in the neonatal study. A logbook of the randomization process was kept but not viewed by the Panel. • parents in both studies were given every opportunity to refuse to enter their babies in the studies (29 of 248 (12%) of families in the neonatal study and 27 of 62 (44%) families in the hypoxia study declined). Family wishes were respected and the parents were supported if they wished to withdraw their babies during the studies (two did).
The issue raised about allegations of forged consent is impossible for me to address. It requires a forensic analysis of the consent forms, which are all available, together with a questioning of the staff involved in the consent process. I welcome such an investigation. Contrary to the stated aims of the report, there are 9 direct and 8 implied criticisms of me as an individual. There was no recognition of the possibility that the complaints about the research of which I was a director could be related to a wide-ranging campaign to discredit the child protection work that I was, and many other paediatricians are, undertaking. The Panel's exploration of fabricated and induced illness in children was superficial and outside the terms of reference for their inquiry. Overview The Griffiths' Panel report [1] makes extensive criticism of the performance of a randomised controlled study of negative extrathoracic pressure ventilation in neonatal respiratory failure [2], particularly in relation to the administration of the study, the obtaining of consent and the records kept. The report has been used as a basis for recommendations on the governance of research. However, the Griffiths' Panel has made a number of inaccurate statements regarding the CNEP and hypoxia studies. These need to be corrected to ensure scientific probity, to maintain the professional reputations of all those who contributed to or reviewed the research work, and to help prevent the unjustified, or inappropriate, erosion of public confidence in beneficial therapeutic innovations and in the value of clinical research in vulnerable subjects such as critically ill infants and children. The Panel provided little indication of the information they would require to the members of the research team that they interviewed. The Panel were not given most of the available and relevant documentation, according to a copy of the information provided to the Panel that was given to me by the Trust in May 2000. The Report does not state which documents have been examined. The Report does not provide a complete list of individuals who were interviewed. Drafts of the report when completed by the Panel were not shown to the members of the research team who were criticised to ensure that they could respond to issues of fact before it was made public. I do not understand why it took 8 months after the conclusion of the interviews with research staff for this Report to be made public. It was essential for the Panel to ensure that they had access to complete information so that their report would be accurate. MHCN Ltd. should carry some of the responsibility for this. Based on the inaccuracies in the report, I conclude that documentation was either not supplied or was not examined in sufficient detail. The panel must have been aware that at least some of the complainants they interviewed were part of a campaign, to discredit me and other health professionals involved in the detection of life-threatening child abuse (in particular illness induced or fabricated in a child)[3]. This work involved the detection by covert video surveillance of intentional suffocation, poisoning, and other forms of extreme cruelty in 33 families, in a proportion of which previous children had been killed by their parents. It is extraordinary that the Panel made no mention of this in their report. This campaign is led by Mrs Penny Mellor, (whom the Panel interviewed, producing in their report half a page of points she had made about research governance) and Mr Brian Morgan, a freelance journalist. I do not know whether the Panel interviewed him or received evidence from him. I informed the Panel of the existence of this campaign against me and of the address of the website heavily contributed to by Mrs Mellor (a self proclaimed child advocate who stated that she represented a number of families) and Mr Morgan (www.msbp.com). At approximately the same time that the Griffiths' Panel was established at the beginning of 1999, allegations about my child protection work, my personal conduct and my research were formulated in an official letter by a senior manager in the Trust to Mrs Mellor on 26th January 1999 and shortly afterwards posted by Mrs Mellor on the Internet. This letter followed allegations made by Mrs Mellor to a senior manager in the Trust, and entered in a written contemporaneous file note as follows: "PM (Mrs Mellor) believes DS (me) was abused by his mother. He does not like mothers. He seems to go for the boys when they are a certain age. Probably at the age when he realized he was being abused. Sado masochist. Thinks all boys are at risk from their mothers. If you look at all the cases he has referred, most will be boys between 9-12. Did he have long spells in hospital as a child which were mother induced? PM also thinks DS may also be into baby racketeering in Bosnia, with M Samuels. …… PM thinks we have enough now to suspend DS" Currently I am suspended by the Trust while they investigate these serious but unsubstantiated allegations against me. Additional information relevant to this campaign is given in Appendices 1 and 2. My response to the Report of the Griffiths' Inquiry is divided into five sections: (1) the trial of CNEP in neonatal respiratory failure (2) the study of responses of infants to breathing 15% oxygen (3) the study of CNEP in bronchiolitis (4) the process by which the Panel reached their judgements, and (5) other issues. Excerpts of the Griffiths' report are typed in bold, with my comments in plain text. Click here to continue reading the remainder of Dr Southall's Response to the Griffiths Report in MS Word format. Related Links We present a collection of articles written from the Lancet on the independent study regarding the above. The titles are as follows :Southall’s CNEP trial more than stands up to scrutiny Download PDF document of Lancet Articles on CNEP issues Baby Breathing Aid Study Cleared Study Vindicates Doctor Behind Baby Experiment
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