Seroxat probe sparks web hits

A WEBSITE and helpline run by a Huntingdon woman received more than 2,000 hits in a single day – after a BBC Panorama programme investigated the anti-depressant drug, Seroxat. Following the screening of Secrets of the Drug Trials last week, 2,416 people c

A WEBSITE and helpline run by a Huntingdon woman received more than 2,000 hits in a single day - after a BBC Panorama programme investigated the anti-depressant drug, Seroxat.

Following the screening of Secrets of the Drug Trials last week, 2,416 people contacted the Seroxat User Group which was founded by Janice Simmons.

The 57-year-old grandmother set up her group after her second husband John Having was told by doctors he was addicted to anti-depressants and would have to take them for life as the withdrawal symptoms are so severe. John, 56, a lorry driver, took Seroxat for 10 years and has been on another anti-depressant, Lustral for the past six years.

In the Panorama programme, Seroxat manufacturer GlaxoSmithKline (GSK) was accused of withholding data about the drug and increased risks of suicide and suicidal thoughts in children.

GSK denied withholding any information and said it was only when all of its research data was analysed together that the increased suicidal thoughts were revealed. It also points out that Seroxat was never licensed for children in the UK. However, UK doctors did prescribe the drug.

Following the documentary, Mrs Simmons is now calling for an independent investigation into GSK and compensation for people addicted to Seroxat.

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Mrs Simmons began her Seroxat Users Group in 2002 and has a large collection case histories of Seroxat users - including another hundred told to her last week after Panorama went out.

One similar experience highlighted by the BBC was the suicide of an 18-year-old woman from Brighton who hanged herself three years ago after being prescribed Seroxat for menstrual problems.

An empty packet of the drug was found nearby.

Mrs Simmons told The Hunts Post: "This documentary is the recognition of a problem I have been fighting for over the past four years.

"The most dangerous time for people taking anti-depressants is when you first go on them, when the dose is raised and when you try to come off them.

"We need to get the word out that these drugs can be dangerous for adults, too. Medicine is applied too generally and people react differently to it.

"We want people to write to their GPs asking for action. People have lost their lives, their families, their jobs. So many people have lost so much because of a little tablet."

INFORMATION: The Seroxat User Group's website, which includes advice for coming off anti-depressants, can be found at www.seroxatusergroup.org.uk

GLAXOSMITHKLINE strongly denies the allegations made by Panorama that it has acted in any way improperly.

We are extremely concerned that as a result of the programme, patients will be anxious about using their anti-depressant medication.

Patients concerned by issues raised in the programme should seek advice from their doctor.

Depression is a severe and disabling condition. A well-recognised, tragic outcome of the disease, particularly among young people, is suicide.

Careful monitoring of all patients is essential, regardless of whether they are taking medication or not.

In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients, including those under the age of 18, who suffer from depression and we refute any allegation that we have failed in this duty.

GSK conducted nine studies, over eight years, to examine the use of Seroxat in treating patients under the age of 18 with depression and other psychiatric disorders, as treatment options for these vulnerable patients are extremely limited.

GSK utterly rejects any suggestion that it has improperly withheld drug trial information.

Results from its paediatric studies were documented and submitted to regulators in accordance with regulatory requirements. Results were also presented publicly, published in scientific journals and are available on GSK's website.

No suicides were reported in any of the nine paediatric trials conducted by GSK. When reviewed individually, none of these trials was considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide. Only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal thinking or attempted suicide revealed in those paediatric patients taking Seroxat. GSK brought this analysis to the attention of the regulatory authorities, including in the UK.

GSK does not promote its medicines for indications for which they are not approved. The company strongly refutes any suggestion that Seroxat was promoted to UK doctors for use outside the terms of the UK marketing authorisation.

GSK, in 2004, further demonstrated its commitment to data transparency by creating an on-line database, called the Clinical Trial Register (CTR). This is a record of detailed summaries of more than 2,800 clinical trials and is available at http://ctr.gsk.co.uk

* Since the screening of the Panorama programme on January 29, Labour MP for Newport West, Paul Flynn, has tabled a series of Early Day Motions, calling for:

* The establishment of an independent drugs testing agency funded by a levy on pharmaceutical companies modelled on the Italian Agenzia Italiana del Farmaco.

* He challenges GlaxoSmithKline to act on its threat to sue the BBC, challenging claims that it withheld data on the link between Seroxat and risks of suicide in children.

* He calls for GSK to be prosecuted and for the Government's Medicine and Healthcare Products Regulatory Agency to accelerate its investigation into GSK, begun three years ago.

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