Christmas Adjournment

The best Christmas present that I can give hon. Members is to stick to 10 minutes, so I shall talk about Christmas at the end of my speech rather than at the start. One of the issues that has been raised with me over the past year is the regulation of the medical profession, which is a complex matter. The role of the General Medical Council is to prevent people who are a danger to patients from practising. We also have the Council for Healthcare Regulatory Excellence to back up the GMC. With the GMC losing its medical majority, it sounds as though everything is going the right way. However, all is not well in the sphere of medical regulation. The GMC is effective in preventing doctors from forming intimate relationships with their patients, and it also does a good job when it is clear that someone is totally incompetent. However, the GMC fails substantially when it comes to protecting patients from harm caused by doctors. One of the challenges in regulating any sphere of human endeavour is how to handle conflicts of interest, which arise particularly in the sphere of medical research. For a doctor involved in research to obtain the respect of his or her peers, papers based on original research are needed. They lead to international conferences and being fêted on the world stage, but patients just want good health. Josef Mengele’s activities during the second world raised serious questions about medical research ethics. He performed a lot of experimentation on unwilling human subjects that was not in the interests of the patients concerned, and did them harm. The challenge for medical regulation is to ensure that the interests of the patients come first, but sadly, over the past 20 years it has failed to do so. The best example of that comes from the research of Dr. David Southall. 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. It is not clear how many of those children were subjected to sleep studies, or what the outcome was, but what is clear from the experience of Karen Brenchley and Davina Hollisey McLean is that their children were forced into the experiments, and probably suffered brain damage as a result. Dr. Southall did much of the research at the Royal Brompton hospital—the focus of other concerns about brain-damaged babies that were raised by the Mayor of London when he was a Member of this House, and by the hon. Member for South Norfolk (Mr. Bacon) more recently. 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. The problem is that over decades he was allowed to continue to do research just as damaging as that of Josef Mengele, without proper action by the authorities. Notwithstanding many requests to his employer, the University Hospital of North Staffordshire, there has been no action to tell patients what has been happening. One of the most worrying aspects is that the records of babies who suffered sudden infant death give no indication of what was done to help them, such as giving additional oxygen to prevent the death. Earlier this year, in Yokohama, a German doctor presented an abstract of research referring to babies being monitored during a SID. What that means is that records were kept of babies as they died. The abstract includes the words:"““One infant only began to gasp 13””—" minutes—"““after the first monitor alarm"," and"““The latter data were confirmed in a similar study observing gasping in 23 of 24 infants immediately preceding death.””" I share the concern of the chief executive of the Royal College of Paediatrics and Child Health, in that"““I would certainly hope that gathering research data was secondary to preventing the deaths of children.””" However, much as I have requested an investigation as to the provenance of the information, no investigation has occurred. That particular doctor worked for some time with Dr. Southall on projects that could have led to such measurements being taken. 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. Floating around in the background are arguments claiming that the rules have been tightened up and what was permissible years ago is no longer permissible. The rules in the Nuremberg convention were quite clear—