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Issues - Chemical abuse of Children
How much did the drugmakers take in
profits for the chemical abuse of our children??
Drug companies have deliberately suppressed
evidence that many antidepressants are unsuitable or even
dangerous for children, according to psychiatrists and child
health experts.
Researchers uncovered unpublished data about clinical trials
of the most popular antidepressants on the market, known as
selective serotonin re-uptake inhibitors (SSRIs), which raise
serious doubts about prescribing them to children.
Published studies have so far indicated that the benefits
have outweighed risks for all five drugs studied - Prozac,
the brand name for the drug fluoxetine, paroxetine, sertraline,
citalopram, and venlafaxine.
But the review published today in medical journal the Lancet
showed this was true of only one, the leading brand, Prozac.
The others at best were not proven to help children and at
worst linked to an increased risk of suicide or suicidal thoughts.
A separate editorial in the Lancet added that an internal
memo from drug giant GlaxoSmithKline, the makers of paroxetine,
had demonstrated how it "sought to manipulate the results
of published research".
It said: "The story of research into SSRI use in childhood
depression is one of confusion, manipulation, and institutional
failure. In a global medical culture where evidence-based
practice is seen as the gold standard for care, these failings
are a disaster."
The six psychiatrists and child health experts who carried
out the research also suggested that negative clinical information
about the drugs had been deliberately withheld.
The researchers obtained information about the unpublished
clinical trials from the government's committee for the safety
of medicines, which has access to confidential data. But the
pharmaceutical companies involved refused every request for
access to their unpublished data.
The researchers, led by Dr Craig Whittingdon from University
College London, wrote: "We understand that some trials
might have been submitted for publication, and that negative
results could be more difficult to get published.
"Nevertheless, the possibility remains that researchers
writing these reports might not have been able to disclose
the findings from negative unpublished trials."
The researchers warned that the drug companies attitude risked
compromising the guidelines issued by the National Institute
for Clinical Excellence (Nice), which were underpinned by
evidence published in peer-reviewed journals. Although Nice
accepted submissions about non-published data, this was only
done on the understanding that the information was publicly
available.
The researchers wrote: "Drug sponsors who withhold trial
data (or do not make full trial reports available) undermine
the guideline programme, which can ultimately lead to recommendations
for treatments that are ineffective, cause harm, or both."
Paul Corry, the head of policy and campaigns at the mental
health charity Rethink, said the pharmaceutical industry,
patient groups and regulators must be "open, honest and
transparent with each other about people's real experience
of using [SSRIs]."
He added: "Only when everyone - including children and
their carers - has access to all the information, can they
exercise informed choice about the medicines they use."
The unpublished data examined by the researchers included
information from clinical trials as well as findings not included
in the published studies.
In the case of paroxetine, citalopram and venlafaxine there
was clear evidence of a small raised risk of suicide or suicidal
thoughts. A weak suicidal association with sertraline was
also identified.
For none of these drugs was there evidence of sufficient benefit
to outweigh the risks.
The UK committee on safety of medicines last year banned the
treatment of childhood depression with any SSRI except Prozac.
But so far the government department controlling food and
drug administration in the United States has not taken action
over the drugs.
http://society.guardian.co.uk/mentalhealth/story/0,8150,1201844,00.html |