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Shamed Glaxo Reveals Truth on 'Suicide' Drug
Source: Daily Mail; London (UK)

BRITAIN'S biggest drugs firm caved in dramatically yesterday and revealed research which shows a leading antidepressant can cause children to attempt suicide.

In an astonishing U-turn, Glaxo-SmithKline finally published full details of nine scientific studies and two clinical reviews which expose the dangers posed to under-18s who take Seroxat.

Children on Seroxat are twice as likely to have suicidal thoughts than those on a dummy pill, it emerged.

Alarmingly, one study showed six youngsters on Seroxat wanted to kill themselves, compared to just one taking a placebo pill.

The drug was also linked to distressing side effects including hostility, insomnia, dizziness, tremors and emotional irritability.

Campaigners say the damning findings were suppressed for up to a decade while thousands of teenagers and children as young as six continued to be given the pills to ease depression.

At one point, doctors had even hailed Seroxat as a 'wonderdrug' to help people overcome shyness.

The firm is facing a major lawsuit amid allegations that drug regulators were duped into thinking Seroxat which is worth Pounds 2billion a year to Glaxo was safe for children.

A number of youngsters are known to have committed suicide while taking the drug, but it was not until last year that doctors were banned from prescribing it to under-18s because of the suicide risk.

Some estimate that more than 50,000 under-18s in the UK were prescribed Seroxat between 1990, when it was licensed here, and last year when the ban was imposed by Government medical regulators.

Anguished parents have complained that their children became suicidal while on Seroxat then showed horrendous withdrawal symptoms when they tried to come off it.

A civil lawsuit has been filed against Glaxo in the U.S. by New York State attorney general Eliot Spitzer, who claims the firm suppressed at least four studies on the drug.

More than 3,000 UK families have also started legal action against Glaxo seeking compensation for their ordeal. They include a number of parents whose children committed suicide while on Seroxat. Full details of the controversial studies were published on the Internet only after the medical establishment turned on Glaxo.

In an unprecedented attack, the respected Lancet medical journal last week accused the drugs giant of losing touch with its basic humanity over the Seroxat scandal.

In an editorial, the journal said: 'GSK appears to be floundering in the semantic depths.

'While it has been earnestly parsing the meaning of "suicidal thinking" and "publicly", it appears to have forgotten what lies behind those words people. The time has come for these matters to be revealed in a bright and public light.' The Lancet said the safety and efficacy of Seroxat in children had been tested in 'at least five studies sponsored by GSK, only one of which has been published'. It revealed that, although the results of this trial were mixed, they were heralded in a memo as showing 'remarkable efficacy and safety in the treatment of adolescent depression'.

The Lancet also poured scorn on Glaxo's argument that trials data was made public. This was done at scientific meetings attended only by specialists and published in the letters pages of medical journals.

Medical authorities here are investigating whether Glaxo complied with legal requirements to make all relevant clinical trial data on the drug available.

Last night. a leading consultant psychiatrist who was among the first to question the safety of Seroxat, said the publication of the Glaxo-funded Seroxat studies was too little, too late.

Dr David Healy, of the University of North Wales, said: 'If the data had been out there from the start, we could have avoided some of the problems we have seen with Seroxat.

'If people had been aware of the evidence from the trials and seen the risks, they could have reduced the risks of adverse events happening. Parents could have been told to keep a closer eye on their children.' The nine studies were made available to the Government's regulators, the Medicines and Healthcare Products Regulatory Authority, only in May last year.

The details lay behind the decision to ban doctors from prescribing Seroxat to under- 18s. A spokesman for GlaxoSmith Kline last night said it had already communicated the trials data to the medical community in the normal way through meetings, letters and papers over the last decade.

Medical regulators were also given the data as soon as the risk of suicidal thoughts became clear.

But he added: 'We thought in the interest of transparency and given the interest in this area that we would publish all the documents on the website.

'We have made no attempt to hide results or mislead regulators or the medical community.

Studies individually show no consistent evidence of a problem in terms of the safety issue.

'It really was not until the nine studies had been completed and we had combined it with further review in 2003 that we saw there was a potential signal.'

The young victims who died in torment

JAMIE HOOLE was 18 when he killed himself two months after he started taking Seroxat.

The talented pianist and artist was prescribed the drug after he lost his self-confidence and began to withdraw from everyday life.

More than a year after he hanged himself, his mother Jean Bambrough is convinced her son would still be alive had he not been on the drug.

Miss Bambrough, 43, a personal assistant from Northwood, North- West London, said: 'It was like prescribing him a loaded gun.' Jamie, a builder, turned to selfharm cutting his arms, legs and stomach with a knife. Not long after, his 13-year-old brother Daniel came home to find him hanging by a belt.

Adrian Keegan, 19, had been taking Seroxat for just 26 days when he committed suicide.

He was diagnosed with depression after his relationship with his girlfriend broke down and was prescribed the drug by his GP in 2001.

His father Christopher found his body hanging in his flat. Mr Keegan, from Market Drayton, Shropshire, said: 'There needs to be more information and better control as it is given out far too easily, like sweets.' Sharise Gatchell took her own life at 18 just days before British GPs were banned from prescribing Seroxat to children.

She was first prescribed the drug as a 16-year-old GCSE pupil. Her personality rapidly changed and she began to harm herself.

After coming off the drug, she secretly began taking it again two years later to help her depression.

After 17 days, she hanged herself.

Her mother Stephanie, 44, from Newhaven, East Sussex, said: 'Words cannot describe what we've been going through.' Lucy Sullivan was prescribed Seroxat for depression but weaned herself off it after she tried to kill herself by slitting her wrists.

Now the 24-year-old blames it for depriving her of 18 months of her life.

Soon after she began taking the drug at 19 for clinical depression, her personality changed for the worse.

She became violent, lost touch with her friends and lacked the will to find another job after she was made redundant.

After almost 18 months on the drug, Miss Wilson, from Bromsgrove, Worcestershire, tried to kill herself. 'I would like to see Seroxat completely banned,' she said.

The secret studies and what they found

BETWEEN 1993 and 2003, Glaxo-SmithKline financed a series of studies to find out if Seroxat was safe, and if it worked, in children.

They involved more than 1,600 youngsters, some aged seven, suffering from either major depression, obsessive-compulsive disorder or extreme social anxiety.

All the studies split patients into two groups of equal size: one group took Seroxat while another took a placebo, or dummy, drug.

The studies repeatedly showed that 'serious adverse events' were much more common in those taking Seroxat. Serious side-effects including suicidal thoughts, extreme hostility and worsening depression were between two and six times more common among the groups taking Seroxat.

Here are some of the most startling findings, using the study numbers given to them by GSK:

STUDY 716 Conducted in U.S. and Canada.

265 patients aged seven to 17.

Five patients have suicidal thoughts or attempt suicide, compared to one in the placebo group.

Study 377 UK, Italy, Belgium, Spain, Mexico, Holland, Canada, South Africa.

286 patients aged 13 to 18.

22 in the Seroxat group suffered a serious adverse event a rate twice that of the placebo group.

And the drug didn't even work, the study found. Researchers wrote: 'The results failed to show any superiority for paroxetine [seroxat] over placebo in the treatment of adolescent depression.'

Study 701 U.S. and Canada. 206 patients aged seven to 17. Six patients on Seroxat had serious adverse effects such as emotional instability and worsened depression compared to one on the placebo.

The study also failed to find any evidence that Seroxat was more effective than placebo in treating depression.

Study 329 U.S. and Canada. 190 patients aged 12 to 18. Serious adverse events seen in 11 patients on Seroxat, compared with two on the placebo.

These included suicidal thoughts, hostility and worsening depression.

Study 676 U.S., Canada, Belgium, South Africa. 319 patients aged eight to 17. Serious side-effects in three on Seroxat, compared to one on placebo.

Nine on Seroxat had to drop out of the study as a result of side- effects, compared to two on placebo.

Study 704 U.S. and Canada. 207 patients aged seven to 17. Severe hostility and suicidal thoughts in three Seroxat patients and one of the placebo patients.

Three times as many in the Seroxat group had to have their dose reduced because of sideeffects, and three times as many had to be withdrawn from the study because of side-effects.



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