Baby probes pile up
By Dave Blackhurst
Research carried out by the North Staffordshire Hospital is the subject of five separate investigations.And now Staffordshire police are carrying out preliminary inquiries into allegations that parents' signatures were forged on consent forms giving permission for their children to take part in clinical trials.
Doctors have flatly denied the claims and are fully co-operating with all the investigations although they have not been officially notified about any police involvement. Those five probes are into at least three research studies plus a type of treatment which has become standard on hundreds of sick babies.
At the centre are the controversial CNEP tanks used in a study on 122 sick and premature babies between 1989 and 1993. Forty-three died or suffered brain damage compared to 32 from another 122 babies undergoing traditional ventilation.
Doctors say the different outcomes were not statistically significant but a row flared several years later when some parents claimed they had not signed consent forms to allow their babies to be used in the experiments. That has been continually denied by the hospital authorities which say they have fully signed forms from parents.
CNEP is still used to treat older babies and its safety is now being investigated by an external expert. Then the focus of the probes turned to another technique - also started in North Staffordshire Hospital in the early 1990s - involving the use of secret video cameras to film babies being abused by parents suspected of suffering from Munchausen's Syndrome by Proxy.
Mothers of babies subsequently taken into care made complaints to the hospital and a review ordered by the Government this Spring into the different strands of research has taken evidence from them.
The third trial was on 34 new-born, healthy babies who had the oxygen levels they were allowed to breathe marginally reduced. None came to any harm in the hypoxia trials yet one mother, Justina Hancock from Ball Green, made an official complaint last year that she had not been made aware her then three-month-old son, Ryan, was taking part in research.
She said at the time that she assumed he was simply being monitored while asleep.Doctors hit back angrily at claims the babies were exposed to the risk of heart and lung problems and hospital medical director Keith Prowse said: ‘‘The risk from such a small oxygen reduction was minimal - the same as faced by thousands of babies who fly every day.''
A fourth probe followed a string of complaints from campaigner Penny Mellor, leader of a group of mothers suspected of having Munchausen's Syndrome.
The fifth investigation came when the hospital received more complaints that the CNEP system was now part of standard treatment even though the trial stopped in 1993.
Officials has called in an independent child health specialist to verify the safety of the system. The Griffiths review ordered by Ministers is to report next month. It held two hearings lasting several days at the Moat House Hotel in Etruria when dozens of parents, doctors and others gave evidence.
Doctors have already admitted that the only way ground-breaking research can be carried out on desperately ill babies is by asking their parents for permission at a time when they are extremely traumatised - and that is understood to be one of the issues Griffiths will try to address.
The department's senior paediatrician Professor David Southall has volunteered to carry out no more child abuse work pending the outcome of that inquiry.
War of words erupts between campaign rivals
A war of words today broke out between two groups of parents campaigning against research at the paediatric department at the North Staffordshire Hospital.
It follows a public meeting on Tuesday during which it emerged Staffordshire police were making preliminary inquiries into claims that parents' names were forged to enable their babies to be used in research.
The meeting was organised by Penny Mellor, who leads a group of mothers suspected of abusing their children because of the condition Munchausen's Syndrome by Proxy.
At the meeting in the Port Vale pub, Burslem, were mothers who lodged complaints against the hospital over the use of their babies in the so-called CNEP study into breathing tanks.
Today Debbie Henshall, who is spearheading the fight against CNEP, said: ‘‘We wanted nothing to do with this meeting. ‘‘Penny Mellor knows nothing about CNEP and for her to get involved in the CNEP campaign will only confuse mothers. It means that misleading information is being given.''
Ms Mellor, from Coven, near Stafford, became involved when she was approached by mothers when she ran a child abuse agency in North Wales. She said today: ‘‘I arranged the meeting after continual requests from CNEP mothers who were unhappy with the length of time everything was taking. They came to me - not the other way round.
‘‘We don't want to be sitting here in exactly the same position in two years time so I was asked to try and speed things up. This is something I hope I have done with this meeting. ‘‘I invited Debbie to attend but she declined to come.''
What all these terms mean
The GMC stands for the General Medical Council and is Britain's registration body for doctors. It has the power to strike off, reprimand, suspend, or vindicate medics.
UKCC stands for the United Kingdom Central Council for Nurses, and has the same powers over that profession.
CNEP stands for Continuous Negative Extrathoracic pressure and works by reducing the pressure round a baby's lungs allowing it to breathe unaided.
MSBP, standing for Munchausen's Syndrome by Proxy, is a condition in which parents draw attention to themselves by deliberately harming their babies.
The Hypoxia study involved lowering air pressure round 34 babies, simulating conditions on an aeroplane to see if there was a link between air travel and cot death.
Who is now investigating tank trials?
The General Medical Council (GMC) launched an investigation two years ago after complaints from CNEP parents and has now sought consent forms to cover all babies in that study.
The UK Central Council for Nurses launched its own inquiry at about the same time. That is still ongoing.
Campaigner Penny Mellor - leader of mothers suspected of child abuse because of MSBP - hit the hospital with a string of complaints which have now been referred to two independent experts.
This Spring the Government ordered a review of the authorisation of all research in North Staffordshire by Birmingham University public health expert Prof Rod Griffiths. Two investigators have taken evidence and a report is currently being written.
The latest investigation follows a complaint that the procedure is still used as standard treatment on older babies. An external expert is to review its safety.
At cutting edge of controversy Angela Woolridge brandishes two pieces of paper. One bears the signature of her husband, Wayne. A second details her husband's name, Wayne Woolridge. Angela says they are different.
The hospital says her husband signed the consent form on the day her premature baby was rushed into the special breathing chamber.
She says she did not know her baby had been involved in the trial until she was contacted by the General Medical Council earlier this year.
Angela, 29, says: ‘‘I was shocked. I had no idea she had been in a medical trial. It had been described to me as a normal incubator.''
Deborah and Carl Henshall from Clayton are the couple who kick-started the campaign against the use of CNEP tanks. Two of their prematurely-born daughters were used in the chambers. Stacey has died and Sofie, now six, is brain damaged. The couple's campaigning has led to three of the investigations taking place into the hospital's paediatric department.
The pressure they put on MPs prompted Government ministers to launch a review into medical research in North Staffordshire. That reports next month and the Henshalls hope it recommends an end to CNEP except as a treatment of last resort, and a toughening up of local ethics committees.
Mother of two Debbie Bestwick has launched a counter campaign for the CNEP tanks to stay after claiming they saved the life of her son Ethan. Now aged nearly two, he was constantly stopping breathing and turning blue when he contracted the chest illness bronchiolitis. Then he was placed in one of the controversial chambers and thehis health was transformed.
Debbie, of Harriseahead, said; ‘‘Myself and husband Sean are convinced the CNEP tanks saved his life.‘‘They were also used on our other son. While they did not help him, they did him no harm either.I fear this bad publicity may stop others letting doctors use the tanks on their babies.
Gloria Brown claims that the consent form for her baby was forged have prompted a police inquiry is Gloria Brown from Trent Vale. Her son Joshua died while he was in the CNEP trial in 1993 and then a second son Aaron died after he had been in the same chambers when they became a standard part of treatment at the hospital.
She says the first she knew of the trial was earlier this year when she was approached by the General Medical Council as part of its investigation. A consent form with her name signed on the bottom has been produced. Mrs Brown says: she is not seeking revenge or compensation — simply an assurance that CNEP will be stopped.
Professor David Southall was a paediatrician working at the cutting edge of child health in London when he was head-hunted by North Staffordshire Hospital.
Health officials were delighted when they finally got their man in 1992 and since then he has rarely been out of the headlines. But he brought with him from capital's Royal Brompton hospital two medical procedures which have placed the Hartshill complex in the national spotlight as never before.
And with them has come a catalogue of high profile complaints from parents of babies using the systems. Those complaints have helped bring no less than five investigations into the department where Prof Southall and his team of specialists work.
In fact the plethora of inquires prompted one colleague to say last month: ‘‘We seem to be writing report after report in response to complaints and questions - I don't know where it will all end.''
The professor's ground-breaking achievements have included the setting up of an eight-bed paediatric intensive care unit which has saved the lives of children from an area well beyond North Staffordshire. The unit has been so successful, it has been awarded a Government Charter Mark. And for every parent who has doubted his methods, there have been others who say they owe their children's lives to Prof Southall and will not have a word said against him.
He has admitted privately that some of the criticism has left him shaken. But he has continued to pin his faith in the two most controversial procedures — CNEP tanks to help premature babies with a chest illness and covert video surveillance to trap parents in the act of assaulting their children. On the latter, he has insisted that the need to sometimes protect children from their own parents blots out any civil liberties issue. He claims the method has produced enough irrefutable evidence to protect more than 30 children from further abuse.
The secret cameras are no longer used in North Staffordshire.But they identified a disturbing catalogue of abuse including suffocation, kicking, deliberate fractures and poisoning. In an interview with the Sentinel two years ago Prof Southall said: ‘‘I don't like being criticised but I can understand where it is coming from. A lot of people cannot believe parents could do such awful things to their children and they don't want to believe it. ‘‘One has to look at it in a fatalistic way — that anyone involved in child abuse work will be criticised.''
On CNEP, Prof Southall is among a group of doctors, nurses and other experts who headed research into the system. The team remains convinced in the benefits it has delivered to babies suffering from chest illness. It is based on placing babies in chambers and then lowering the pressure to enable their chests to expand and breathe unaided.
The doctors believe in the technique on babies aged over 10 days because it removes the need for traditional ventilation under which an air tube is pushed down the infant's throat with a risk of trauma and infection.
Away from the hospital, Prof Southall has thrown himself into charity work and is director of the group Child Advocacy International which has brought medical relief to children in world troublespots including Bosnia and Kosova.
The charity is based in Trent Vale and the Professor was awarded the OBE in the New Year's Honours for the his work.
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