AR-News: Drug companies and children

Wed Feb 4 20:51:01 EST 2004

http://observer.guardian.co.uk/uk_news/story/0,6903,1136319,00.html

The Observer. 1 February 2004.
Child abuse probe uncovers deadly role of axed drug.
By Jamie Doward, social affairs editor.

A drug linked to more than 100 deaths is being blamed for a
series of gross miscarriages of justice that have seen
hundreds of parents wrongly accused of child abuse.
A conference drawing together psychologists, social workers
and scientists will hear evidence this week that a drug
called cisapride - used to treat digestive problems and now
withdrawn from the UK market - has resulted in hundreds of
cases of wrong diagnosis.  Experts will claim the drug is
known to interrupt the rhythm of the heart, causing some
youngsters to turn pale and experience breathing
difficulties. Campaigners say the symptoms have prompted
doctors to wrongly accuse parents of trying to smother
their
children.
The revelation will raise further questions about the
validity of the controversial condition Munchausen Syndrome
by Proxy (MSBP) - first theorised in 1977 by paediatrician
Professor Sir Roy Meadow - which suggests some parents harm
their children to draw attention to themselves.  Critics of
MSBP, which has been discredited following a series of
court
cases, fear it blinds social workers, lawyers and judges to
other explanations for apparent child abuse, such as the
side effects of drugs or the symptons associated with a
number of illnesses.
The conference, at Sydney University in Australia, aims to
debunk MSBPand is set to attract worldwide attention. It
will hear calls for a full investigation into cisapride,
which was withdrawn in the US and the UK three years ago
after it was linked to 136 deaths worldwide, including
those
of two British children.  'Given the amount of cases where
cisapride has played a significant part in the child's
treatment and the child's parents have been diagnosed as
having MSBP, it is imperative the Government launches an
investigation into this drug,' said Penny Mellor an
anti-MSBP campaigner.
The Government said last month that it is to investigate
more than 250 criminal cases in which a parent had been
convicted of murdering a child. The decision was taken
after
a series of overturned convictions.  Sally Clark was freed
after spending three years in jail for killing her two
children. Trupti Patel was acquitted of smothering her
three
babies. Angela Cannings, jailed for killing her two sons,
was released by the Court of Appeal last December.
The Government is also planning to ask local authorities to
examine up to 5,000 cases in which children were taken from
their parents in the civil courts and in which MSBP may
have
been cited. Authorities in the US, Canada, Australia and
New
Zealand, are also under pressure to examine cases in which
parents were separated from their children following the
diagnosis of MSBP.
The first civil cases involving parents who claim they were
wrongly separated from their children as a result of MSBP,
are currently being prepared for appeal.  Meadow and
another
paediatrician who has advanced the MSBP theory, Professor
David Southall, are now the subjects of separate inquiries
by the General Medical Council. The Observer has also
learnt
that there are at least four other experts in the field of
MSBP whose work is now likely to be scrutinised by the
health authorities.
Since The Observer highlighted the allegation that MSBP was
responsible for a series of miscarriages of justice last
week, numerous other cases where the parents claim they
have
been wrongly separated from their child have come to light.
In one case in Hampshire, a mother accused of MSBP was
separated from her two seriously ill twins but allowed to
keep her other two children. The twins were eventually put
into care and the mother was forced to give the other two
children up for adoption. She subsequently emigrated to New
Zealand where she alleges British social services contacted
counterparts there with the result that two other children
she had with another partner ended up being taken into
care.
Her case is one of the first that is expected to be
appealed
this year.
Janssen Pharmaceutica, makers of cisapride, declined to
comment.
========================================================

http://www.guardian.co.uk/medicine/story/0,11381,1137559,00.
html
The Guardian. 3 February 2004.
Company 'held back' data on drug for children:
Antidepressant had no effect, leak reveals.
By Sarah Boseley, health editor.

The British manufacturers of an antidepressant drug that
was
last year banned from use in children knew as long ago as
1998 that it did not work and deliberately avoided
publishing the full data because of the risk to their
lucrative adult market, according to a leaked internal
document.
A position paper dated October 1998 shows that managers at
SmithKline Beecham - now GlaxoSmithKline - were concerned
at
the commercial implications of two clinical trials in which
their drug Seroxat was given to children and adolescents
with major depression.
The results of both trials, known as protocols 329 and 377,
showed that the drug was no better than a placebo - an
inert
pill - in alleviating the children's depression. An
internal
unit at the drug company called the Central Medical Affairs
team prepared a strategy.
The target, says the document - leaked to the BBC's
Panorama
team, which has made two programmes on Seroxat - was "to
effectively manage the dissemination of these data in order
to minimise any potential negative commercial impact".
About
500,000 adults were at the time taking the drug in the UK.
Seroxat was licensed for their use, but not for use in
children. Even so, some 8,000 to 10,000 children were also
on it because doctors can prescribe an unlicensed drug on
their own responsibility.
The paper says that following consultations within the
company, SmithKline Beecham would not submit any data to
the
regulators to get a statement on the efficacy or the safety
of the drug. It says: "It would be commercially
unacceptable
to include a statement that efficacy had not been
demonstrated, as this would undermine the profile of
paroxetine [Seroxat]." It adds, however, that "positive
data" from the first and bigger study, protocol 329, would
be published in abstract form at a psychiatric meeting the
following month and that a full manuscript of the trial
"will be progressed".
It was eventually published in July 2001 with the
conclusion: "Paroxetine is generally well tolerated and
effective for major depression in adolescents."
It was only last spring, after Glaxo submitted the full
data
from protocols 329 and 377, together with a third study of
depressed children on Seroxat and data from trials of the
drug in children with obsessive compulsive disorder and
social anxiety disorder, that the UK regulator, the
Medicines and Healthcare Products Regulatory Agency (MHRA),
realised that not only was Seroxat ineffective in children
but that a bigger proportion of those taking it in the
trials thought about killing themselves than among those on
placebo. The drug was then banned.
Yesterday Alastair Benbow, GSK's head of European clinical
psychiatry, said the document "draws inappropriate
conclusions and it is inconsistent with the facts".
He insisted that there was no sign of a suicide problem
until all the trials were put together.
Richard Brook, the chief executive of Mind, the UK
organisation for mental health and a member of the Seroxat
review panel convened by the MHRA, said he was appalled by
the revelations in the leaked document. To allow the drug
to
be given to children when there were known side-effects and
it could not be proven to work was "morally and ethically
bankrupt", he said.

Animal experiments have:
a 63% failure rate when detecting human carcinogens
a 75-95% failure rate for detecting drug side effects
a 70% failure rate for detecting drugs which cause birth defects
Success rates lower than those achieved by uneducated guesswork.

This is not science!!

Recommended website: The Absurdity of vivisection
http://vivisection-absurd.org.uk/

Information on animal research available free by EMail from 
vivisectionkills at hotmail.com

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the wild, cruel beast is not behind the bars of the cage. he is in front of it - axel munthe

"Never doubt that a small group of dedicated citizens can change the world. 
Indeed, it's the only thing that ever has."      Margaret Mead
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