Cover-up claims over children's antidepressants

Drug companies may have deliberately suppressed evidence that many antidepressants are unsuitable or even dangerous for children, it has been claimed this week.

Researchers uncovered data that raises serious doubts about prescribing the pills to children but was never made public. Published studies showed that benefits outweighed risks for all five drugs studied. But the wider review showed this was true of only one, the leading brand Prozac.

The others at best were not proven to help children and at worst associated with an increased risk of suicide or suicidal thoughts.

Writing in The Lancet medical journal, the six psychiatrists and child health experts who carried out the research suggested negative study data may have been deliberately withheld. The researchers obtained information about unpublished trials from the British Government's committee for the safety of medicines, which has access to confidential data.

But every request for unpublished data from the pharmaceutical companies involved met with a refusal.

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 that researchers writing these reports might not have been able to disclose the findings from negative unpublished trials."

They pointed out that medicine guidelines issued by Nice, the National Institute for Clinical Excellence, 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. "Drug sponsors who withhold trial data undermine the guideline programme, which can ultimately lead to recommendations for treatments that are ineffective, cause harm, or both," wrote the researchers.

The drugs involved in the study are known as Selective Serotonin Re-uptake Inhibitors (SSRIs). Besides Prozac (brand name for the drug fluoxetine), the experts looked at paroxetine, sertraline, citalopram and venlafaxine.

- NZPA