E-drug: Antidepressants for children banned in the UK (cont'd)
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And yet, said Dr Healy, "the adverse event [side effect] profile
was worse on Prozac than on placebo. In the Prozac group of
trials there were four suicidal acts among children and zero on
placebo." (from E-drug posting below).
Dear e-druggers,
I trust that all of you that know a bit of statistics and are
familiar with clinical trials will immediately spot that the total
number of clinical events (suicides) was so tiny that it is much
more likely than not that these results were due to chance rather
than causality. The power of these studies must be close to zero.
Valeria
Dr Valeria Frighi
Oxford Centre for Diabetes, Endocrinology and Metabolism
Churchill Hospital
Oxford
UK
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E-drug wrote:
E-drug: Antidepressants for children banned in the UK (cont'd)
-------------------------------------------------------------------------[Copied as fair use. HH]
Rules on medicines 'need big shake-up:' Anti-depressant ban for
children reveals flaws in system, says MindThe Guardian, London, 11 December 2003
By Sarah Boseley, health editorThere were calls yesterday for an independent review of the
regulation of drugs in the UK, following the banning of most
modern anti-depressants from use in children some years after
pharmaceutical company trials showed up a problem. Mind, the
leading mental health charity, said the regulatory process was
fundamentally flawed and needed to be overhauled if consumers
were to have any confidence in it."It is totally unacceptable that for a significant period 50,000
children and adolescents in the UK have been prescribed
anti-depressant drugs that were not licensed for use but it is only
now being demonstrated that they do not help and can indeed
cause harm," said Richard Brook, Mind's chief executive."The loud voices of users and a high profile campaign started a
course of events that led to [Tuesday's] announcement.
Long-term, effective and strong regulation has not been evident
or provided the type of information consumers have the right to
expect."As the Guardian revealed yesterday, four antidepressants of the
selective serotonin reuptake inhibitor (SSRI) class were
effectively banned from use in children by the Medicines and
Healthcare Products Regulatory Agency: Lustral (known as
Zoloft in the USA), Cipramil, Cipralex and Faverin. Two others,
Seroxat and Efexor, were banned earlier this year. None was
licensed for use in children, but doctors can prescribe unlicensed
drugs if they feel it is appropriate.The MHRA reached its decision after an expert working group
reviewing the SSRI class of drugs was given access this year to
the full trial results of some in children. Although these were
carried out in the mid to late-1990s, the full data had not been
given to the MHRA. These showed that more children and
adolescents became suicidal on the drugs than on placebos
(sugar pills).The review of the SSRIs was only set up at the end of last year
because of mounting public pressure, following allegations that
people became hooked - unable to stop taking them without
suffering severe withdrawal effects - and in some cases suicidal."There are enormous commercial interests trying to influence
decisions about the use of drugs," said Mr Brook.
"Pharmaceutical companies represent the second largest
industry in the UK. The public needs to have confidence that
their health is being properly protected - particularly where
children are concerned."The companies are not happy with the MHRA ruling. Pfizer,
which manufactures Lustral, said in a statement: "Pfizer
disagrees with this guidance based on a thorough review of our
clinical trial database ... Pfizer believes that the robust clinical
programme involving sertraline suggests no increased risk of
harm to any population, including children and adolescents."One drug from the SSRI class, Prozac, has not been banned,
but the psychopharmacologist whose researches started the
concerns over suicides said yesterday that the trial data in
children did not show it was superior in safety or efficacy to the
others. David Healy, director of the North Wales department of
psychological medicine, said there had been two trials of Prozac
in children - one reported in 1997 and the second in 2002. The
drug's performance in the first showed little effect.In the second trial, however, although Prozac did not lift
children's depression more effectively than the other SSRIs, it
scored better because the children in the comparison placebo
group did not do as well as in trials of other drugs.And yet, said Dr Healy, "the adverse event [side effect] profile
was worse on Prozac than on placebo. In the Prozac group of
trials there were four suicidal acts among children and zero on
placebo."There is some concern now that children on SSRIs will be
switched by doctors to Prozac, when the best alternative for most
would be non-drug therapy. Mind said yesterday, however, that
there is a shortage of professionals trained in other approaches
which can help in depression. Mind and the MHRA say it is
important for children on SSRIs not to stop taking them
suddenly, but to consult their doctor.
--
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