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Mental health

SSRI dangers for children 'suppressed'

Press Association
Friday April 23, 2004

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Researchers uncovered unpublished data about clinical trials of the most popular antidepressants on the market, known as selective serotonin re-uptake inhibitors (SSRIs), which raise serious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The researchers obtained information about the unpublished clinical trials from the government's committee for the safety of medicines, which has access to confidential data. But the pharmaceutical companies involved refused every request for access to their unpublished data.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remains that researchers writing these reports might not have been able to disclose the findings from negative unpublished trials."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.

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