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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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