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Friday 23rd August 2019

Drug giants told to tell truth

27th February 2008

The pharmaceutical industry comes under fire after antidepressant drugs are discredited.


An analysis of published and unpublished clinical trials on antidepressants, including Prozac and Seroxat, has triggered the attack by senior figures in medical research. They now fear that other products may be ineffective, exposing patients to drugs which could be useless or harmful. However, doctors do warn patients taking the drugs not to stop without consulting their GPs.

For the first time UK, Canada and US researchers successfully used freedom of information legislation to obtain all data presented to regulators when companies applied to license their drugs. Over the past 20 years the drugs, known as selective serotonin re-uptake inhibitors have earned billions of pounds for their makers. This latest finding suggests the money may have been misspent. The law requires drug companies to provide all published and unpublished data on the drugs when applying to the regulatory body for a licence.  In the case of the National Institute for Health and Clinical Execellence (NICE) this does not apply as they assess only cost and effectiveness and recommend which drugs should be used by the NHS.

Peter Littlejohns, the clinical and public health director of NICE, said: "The regulatory authorities have access to everything. Obviously we have access to the published data and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not. We have no power to demand it. The issue is that it relies on the good will of the industry."

Legislation to compel the drug industry to publish its results was included in Labour's manifesto at the 2005 election and last month the Commons Health Select Committee demanded that NICE be given unfettered access to all clinical trial results.

The government said they were pursuing a voluntary approach from companies as they had been told that compelling the industry to publish trial data would not be allowed.

GlaxoSmithKline, maker of Seroxat, said it "fully endorsed public disclosure of all clinical trial results" and had published all data relating to Seroxat on its website "regardless of study outcome".


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