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Statement about the Hearing at the GMC over the CNEP Study 1989-1992 13th May 2008, 12:12 am An 8-week Fitness to Practice Hearing is just starting at the General Medical Council for three consultant paediatricians from the University Hospital of North Staffordshire, namely David Southall, Andy Spencer and Martin Samuels. This is with regard to complaints about the administration of a research project involving newborns in a randomised controlled trial of negative pressure ventilation (CNEP) run in two centres, Queen Charlotte’s in London and North Staffordshire Hospital in Stoke, between 1989 and 1992. The GMC will be looking at whether these issues warrant sanctions against the doctors involved, including erasure of these consultants from the medical register. The study was set up in 1989 by David Southall, Principal Investigator and at that time, Senior Lecturer at the National Heart and Lung Institute, with the help of Martin Samuels, research registrar at the Royal Brompton Hospital / Lecturer at the NHLI in London and Dr Spencer, the Consultant Neonatologist based in North Staffordshire. The first complaints about these issues were made to the GMC by the complainants in the late 1990’s. The allegations were investigated twice by the GMC and dismissed. The second review was because the complainants accused the GMC of an unfair process, as they had not examined first time round all the material (1600 pages) submitted by them. In 2004, the complainants lodged an appeal in the High Court over an issue of GMC process and in late 2005, the Appeal Court ordered the GMC to review the complaint. On third review by a newly created investigation panel, the GMC decided that there were issues relating to the Research Ethics Committee submission, the obtaining of consent, the trial scoring system and the write-up in Pediatrics that could represent the possibility of serious professional misconduct. From 1997 onwards, the complainants lodged their complaints over the research study with numerous other authorities, as well as obtaining national media coverage. Their Member of Parliament, Llin Golding, helped establish the West Midlands Regional Health Authority Inquiry into research governance (Griffiths Inquiry May 2000) - this extended its remit to also look at the diagnosis of Munchausen Syndrome by Proxy. The complainants reported the Medical Director of the North Staffordshire Hospital to the GMC, when in 2000, he released the complainant’s consent forms to counter allegations in an imminent Channel 4 television programme that the form signed for the CNEP study was forged. In a public hearing in May 2001, the GMC accepted the Medical Director’s defence that he was protecting the reputation of the hospital and its children’s unit, and found him not guilty of serious professional misconduct. The complainants have reported ten other doctors to the GMC and two nurses to the UKCC. The current GMC Hearing follows numerous previous enquiries, including: a..a review of Professor Southall’s research for his Trust by Professor Sir David Hull (late 2000) b.. a Staffordshire Police enquiry into allegations of forged consent (completed October 2002) c.. a Trust audit of consent, in which forms for all 244 patients included in the trial were available (October 2001) d.. the West Midlands Regional Inquiry led by Professor Rod Griffiths and reported on 9th May 2001 e.. the Hey-Chalmers Inquiry rebutting the highly critical Griffiths Report (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”), published September 2000, and f.. the outcome from a long term follow-up study by Professor Marlow and colleagues in Nottingham, published in the Lancet in April 2006, which showed no harm from CNEP, and possibly some slightly better outcomes for the treatment group. The research study’s protocol had previously been passed by four different hospital Research Ethics Committees (Queen Charlotte’s, North Staffordshire, Hillingdon and Doncaster Royal Infirmary); it was also alpha-rated by the MRC in a funding application and the final paper was peer reviewed for publication in the world’s leading paediatric journal, Pediatrics. The GMC’s case is principally based on the evidence of Richard Nicholson, a doctor who has practised as an ethicist and a former editor of the Bulletin of Medical Ethics. He has allied himself with the complainants since 1997 and made numerous statements to newspapers, TV and radio objecting to David Southall’s research and child protection work, including the concept of fabricated and induced illness, and the use of covert video surveillance. Dr Nicholson removed his name from the medical register in 2000 for ‘administrative reasons’. Like previous enquiries into the work of Professor Southall, the GMC have again failed to use appropriate expertise and ignored the outcomes of previous investigations. Their actions are part of a concerted campaign against David Southall by those accused of child abuse and their advocates, such as Mrs Mellor. She is a self-appointed advocate for parents and has led a highly public campaign against paediatricians and other professionals who have given opinions in child protection cases, many of which she has described as false allegations. She was convicted some years ago of conspiring to abduct a child from social services. The judge said of her in 2002 that: “impervious to debate, convinced you are right, you have traduced, complained about and harried dedicated professional people working in this difficult area” [Munchausen syndrome by proxy]. In 2006, Professor Griffiths wrote in the Lancet “I think that David Southall and his team have to be congratulated on having done a randomised trial when they did. After our report, material became available which suggested that the design of the trial was better than we had been led to believe, and had it been made available to us we would have written some paragraphs differently, making less of some of the criticisms and referring to the register of clinical trials. The important thing, which we acknowledged in the report, was that the randomised design gave a good possibility of effective longer-term follow-up, which has proved to be the case.” In January 2008, Baroness Golding wrote to the Sentinel, a newspaper based in North Staffordshire, apologising to Professor Southall and stating how sorry she was that her initial concern gave fuel to what could only be described as a witch hunt, aided and abetted by some professional people who surely should know better. Recently, paediatricians voted overwhelmingly in favour of a motion at the Annual General Meeting of the Royal College of Paediatrics and Child Health which declared grave concerns over the Fitness to Practice procedures at the GMC in child protection cases, based principally on the GMC’s actions against Professors Southall and Meadow.
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