Wednesday, May 30, 2007

BMJ - FALSELY CONVICTED Sally Clark dies suddenly


Professor Southall, consultant paediatrician at the North Staffordshire hospital in Stoke-on-Trent telephoned the police, having watched Mr. Clark give an interview on TV, to state that Mr. Clark, rather than Mrs Clark had deliberately suffocated his children. He later reinforced his claims, stating it was "beyond reasonable doubt" that Mr. Clark was a double murderer. Prof Southall recommended that the couple's surviving child, who was at the time being looked after by Mr Clark, be removed from his care. Due to his eminence and experience the local authority seriously considered this.


Dr.Southall's involvement in Hospital Smothering Experiments

House of Commons Hansard and Press Cuttings
EDM 2767

Hemming, John

That this House notes that according to the report written by Professor David Hull for North Staffordshire Trust about the work of Professor David Southall in the report written for the University Hospital of North Staffordshire by Professor McLeish and Dr Durbin, Professor McLeish said that Professor Southall `pursued multiple clinical research studies that were poorly designed and therefore were unlikely to produce new knowledge of worth. More worryingly he appears to have had insufficient regard for the ethical standards that should surround all clinical studies in babies'; believes that such comments are important comments that require proper consideration; is surprised that the University Hospital of North Staffordshire is unable to find a copy of this report; calls for the hospital to find a copy of this report and publish its contents; and further calls for an independent judicial or Parliamentary inquiry into the research and clinical activities of Professor David Southall, the failure of the regulatory system to prevent unethical experiments on babies managed by Professor Southall and the misuse of child protection and judicial procedures both to prevent parents from raising complaints about his research and procure children for his research.

Extract of Hansard - 19th December 2006

Dr. Southall has done much research on sudden infant death—an important area of research, given the numbers of children who have died without a clear diagnosis. Perhaps the biggest project was known as protocol 85.02. Dr. Southall looked at the response of babies to asphyxiation, shortage of oxygen and the presence of carbon dioxide. The experiments were known as sleep studies, and started with about 7,000 babies born in the mid ’80s at Doncaster and Rotherham hospitals.

Phases 1 and 2 of the experiments were quite reasonable. Phase 3, however, involved choking babies for 10 sessions of 10 seconds, depriving them of oxygen by giving them only 15 per cent. oxygen rather than the normal 21 per cent., and then giving them too much carbon dioxide. Parents were not asked for their consent to the experiments; they were merely told, in writing, that they would happen, without any details.

A large number of brain-damaged babies were born in Doncaster in the 1980s. However, the records showing which babies were in the experiments were not in the medical files, because Dr. Southall kept secret files, known as special case files. Although compensation was paid, the causation was not entirely clear. The process expanded with the Office for National Statistics providing details of all deaths from sudden infant death syndrome—about 12,000 cases—so that Dr. Southall could continue his research with the siblings....

...Protocol 85.02 was not the only research project operated by Dr. Southall. He also gave carbon monoxide to babies with breathing problems, caused so much damage to babies in his experiments that they needed resuscitation, and did considerable damage through his experimental continuous negative extrathoracic pressure tanks, which he told others was tried and tested when in fact it was research...

..In essence, what we have is evidence of a doctor managing research likely to lead to brain damage and/or death in infants. There is evidence of a substantial number of babies being brain-damaged at the same hospital. There are also records of babies dying from symptoms that could have been caused by that type of research. However, there is no detailed explanation.

The allegations are very serious, but the system of regulation wants to ignore them. After many years of struggle, the General Medical Council started to hear evidence in November relating indirectly to research. It has, however, now decided to adjourn the hearing for 11 months. What is particularly interesting is the history of the special case files. Those have been stored in all sorts of locations, and they have been involved in criminal prosecutions and in family court actions. At one stage, a parent infiltrated the charity run by Dr. Southall to get access to the files. Court action resulted in their repossession.

In December 2005, it was agreed between the GMC and Dr. Southall that the files should be part of the medical records. However, he has now been allowed 11 months to sanitise them. It is important to remember that there is evidence that the files have already been partially sanitised. Many of the patients are completely unaware that the files exist. I have made numerous requests of the NHS to control the files and legal proceedings are continuing in an attempt to keep them intact. However, the authorities continue to resist this, and to tolerate a major cover-up.


Effect of exposure to 15% oxygen on breathing patterns and oxygen saturation in infants: interventional study

Commentary: Safety of participants in non-therapeutic research must be ensured
Commentary: Ethical approval of study was warranted
Authors' reply

Effect of exposure to 15% oxygen on breathing patterns and oxygen saturation in infants: interventional study

Editorial by Milner
K J Parkins, research fellow, a C F Poets, lecturer in paediatrics, b L M O'Brien, research assistant, a V A Stebbens, research assistant, a D P Southall, professor of paediatrics. a

a Academic Department of Paediatrics, North Staffordshire Hospital Centre, Stoke on Trent ST4 6QG, b Department of Paediatrics, Medical School, 30623 Hanover, Germany

Correspondence to: Professor Southall


Objective: To assess the response of healthy infants to airway hypoxia (15% oxygen in nitrogen).

Design: Interventional study.
Settings: Infants' homes and paediatric ward.
Subjects: 34 healthy infants (20 boys) born at term; mean age at study 3.1 months. 13 of the infants had siblings whose deaths had been ascribed to the sudden infant death syndrome.

Intervention: Respiratory variables were measured in room air (pre-challenge), while infants were exposed to 15% oxygen (challenge), and after infants were returned to room air (post-challenge).

Main outcome measures: Baseline oxygen saturation as measured by pulse oximetry, frequency of isolated and periodic apnoea, and frequency of desaturation (oxygen saturation 80% for 4 s). Exposure to 15% oxygen was terminated if oxygen saturation fell to 80% for 1 min.

Results: Mean duration of exposure to 15% oxygen was 6.3 (SD 2.9) hours. Baseline oxygen saturation fell from a median of 97.6% (range 94.0% to 100%) in room air to 92.8% (84.7% to 100%) in 15% oxygen. There was no correlation between baseline oxygen saturation in room air and the extent of the fall in baseline oxygen saturation on exposure to 15% oxygen. During exposure to 15% oxygen there was a reduction in the proportion of time spent in regular breathing pattern and a 3.5-fold increase in the proportion of time spent in periodic apnoea (P<0.001). rs="0.44,">

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