http://www.independent.co.uk/life-st...es-718086.html

Parents were misled over hospital trials that killed premature babies

A year-long inquiry into a hospital trust that conducted an experimental
treatment on premature babies has concluded that the parents were misled
about what was being done to their children.


A year-long inquiry into a hospital trust that conducted an experimental
treatment on premature babies has concluded that the parents were misled
about what was being done to their children.

Some parents have claimed signatures on consent forms for the treatment,
involving a new type of ventilator, were forged and both the General Medical
Council (GMC) and the police have launched their own investigations.

Ministers are bracing themselves for the highly critical report, to be
published today, into the North Staffordshire Hospital Trust in
Stoke-on-Trent. After the Bristol baby hearts scandal highlighted clinical
failings in the NHS, the inquiry, first disclosed by The Independent last
year, is expected to call for tough new rules governing research.

Of 122 babies given the new treatment between 1989 and 1993, 43 died or were
brain damaged, compared with 32 who died or were brain damaged in a control
group of 122 given conventional treatment. The death rate in the
experimental group was 33 per cent higher, but because of the small number
of babies in the trial the difference was not statistically significant.

The inquiry, by Professor Rod Griffiths, director of public health for the
West Midlands, was ordered by ministers in February 1999 after parents
complained they had never been told the treatment was experimental.

They submitted a 1,600-page dossier to the GMC and the police launched a
criminal investigation. These inquiries have been put on hold pending
publication of the 50-page Griffiths report.

One parent said: "Everything that could have been done wrong was done
wrong."

The doctors at the centre of the investigation, Professor David Southall,
professor of paediatrics at Keele University and a consultant at the North
Staffordshire Hospital trust, and Martin Samuels, a consultant paediatrician
at the trust who specialises in the detection of child abuse, were suspended
last December over separate allegations that they had "harassed" and
"threatened" parents in relation to their child protection work.

However, the criticisms in the Griffiths inquiry, which was widened to
include the child protection work, are expected to range beyond the two
doctors and implicate other members of the hospital's staff. In apparent
anticipation of the inquiry's criticisms, the trust has set up a working
party to produce its own guidelines on clinical research and obtaining
consent.

Professor Southall is a controversial figure who pioneered the use of covert
video surveillance to identify children at risk of child abuse. Although the
method proved successful, and led to 34 convictions between 1986 and 1994,
it incensed parents who complained they had been wrongly accused
ofMunchausen's by Proxy, the attention-seeking disorder in which parents
harm their children to get medical treatment.

The allegations of harassment of parents are the subject of a separate
internal inquiry, which was later split into three strands looking at
employment issues, child protection and research.

Last October, Professor Southall announced that he had been cleared of
allegations in relation to employment issues. In a 3,500-word statement put
out by the British Medical Association, which has supported him throughout,
he hit back at the "orchestrated campaign" to discredit him, accusing
campaigners of seriously interfering with his work.

He said he had been repeatedly threatened, his charity for children in
Bosnia had been infiltrated and burgled and research grants and
international aid had been blocked. He wrote of the "immense strain" on him
personally and the threat it posed to children at risk.

Two months later, on 9 December, he and his colleague Martin Samuels were
suspended by the trust. Although there is normally a six-week deadline for
charges to be presented to a suspended doctor none has yet been made against
Professor Southall and Dr Samuels, almost five months after they were
suspended on full pay. A spokesman for the trust said: "The issues in this
case are so complex and so convoluted it does take time."

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