- Drug companies were accused yesterday of refusing to
release evidence that anti-depressants can be harmful to children.
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- Researchers preparing new National Health Service guidelines
for childhood depression said they were astonished by the lack of co-operation
from the manufacturers of SSRIs, the family of drugs that includes Lustral,
Seroxat and Prozac.
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- With five out of six SSRIs, the risks to children outweighed
the benefits, the unpublished data showed. Previously published data suggested
that the drugs were safe and effective in children. At that time, about
20,000 children were being prescribed the five drugs.
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- The revelation was made by scientists working for the
Government's advisory group on medicines amid concerns that pharmaceutical
companies are suppressing scientific trial results showing products in
a negative light.
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- Last month a leaked memo from GlaxoSmithKline showed
that the company played down evidence that Seroxat was no better at treating
depressed children than a placebo. The document, published in the Canadian
Medical Association Journal, suggested that the company "effectively
manage the dissemination of these data in order to minimise any potential
negative commercial impact".
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- At the time of the leak, GlaxoSmithKline said the memo,
written in 1998, was "inconsistent with the facts". This year
it emerged that Seroxat had been prescribed at "unsafe levels"
since 1990.
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- SSRIs, or selective serotonin reuptake inhibitors, have
never been approved for use with children in Britain but have been used
"off licence" by GPs.
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- Last year the Department of Health warned doctors to
stop using six of the drugs - Lustral, Cipramil, Cipralex, Faverin, Seroxat
and Efexor - on children. Only Prozac escaped the ban.
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- Before the advice was given, the National Institute for
Clinical Excellence (Nice) had asked the National Collaborating Centre
for Mental Health to investigate treatments for childhood depression.
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- Dr Tim Kendall, the co-director of the centre, which
is supported by the Royal College of Psychiatrists, looked first at the
published data on SSRIs and found they supported their use in children.
However, when he and colleagues tried to obtain unpublished trial results,
drug companies refused or ignored his requests.
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- "We asked them for it and they would not give it
to us," he told The Telegraph. Instead, the centre's researchers used
unpublished data obtained by the Government's Committee for the Safety
of Medicines, which has access to confidential findings.
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- Their analysis of all published and unpublished data
showed that the side effects of all but one SSRI outweighed any advantages.
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- Seroxat, for instance, increased the risk of suicidal
thoughts, the team found. The only drug to have benefits in children was
Prozac. Dr Kendall said the companies may have been unwilling to provide
information because it had already been submitted to a peer-reviewed journal.
Some data may have been commercially sensitive.
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- He said: "But I think there is growing evidence
to suggest that drug companies are withholding trials that are unfavourable.
This is worrying because we do lots of work for Nice and we rely almost
solely on published data.
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- "If we had seen only the published data, we might
have concluded that SSRIs were worth prescribing to children." The
researchers called for changes in the law to force pharmaceutical companies
to publish all data on drugs.
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- The Association of the British Pharmaceutical Industry
denied that negative results were deliberately withheld. Richard Ley, a
spokesman, said companies had never pushed for the use of these drugs in
children.
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- "These are not recommended by the manufacturers
and clinicians are not going to use something they do not believe is having
an effect.
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- "The situation is not ideal. It is very difficult
for companies and academics to have all clinical trial results published.
Journals tend not to publish negative results because there is not much
of a story." Drug companies were working to make unpublished clinical
trial data available on a website, Mr Ley said.
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- Andrew Dillon, the chief executive of Nice, said that
drug companies were encouraged to make unpublished clinical trial data
available to its researchers. "But we have no powers to force them,"
he said.
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- Sophie Corlett, of the mental health charity Mind, said:
"There is a tendency to rely far too heavily on drug treatments for
depression in children. This is despite increasing medical evidence that
they don't actually help."
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