Shamed Glaxo reveals research

[Guest guest]

Shamed Glaxo reveals research

Beezy Marsh and Tim Utton, Daily Mail

15 June 2004

BRITAIN'S biggest drugs firm caved in dramatically yesterday and

revealed research which shows a leading anti-depressant can cause

children to attempt suicide.

In an astonishing U-turn,

GlaxoKline 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.

Other stories:

King warns of house price crash

M & S: funds point to Green failure

Market report: Tuesday 14.00

Oil prices hike inflation to 1.5%

Brown longest-serving Chancellor

First-time homebuyers wary

Exel poised for Tibbett bid

Bundesbank 'homes for executives'

People urged to shop benefit frauds

Colleague grabbed my thigh - banker

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 £2bn 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 US 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 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 Glaxo 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 secret studies and what they found

BETWEEN 1993 and 2003, Glaxo-Kline 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 the US 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

US 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

US 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

US, 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

US 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.

[Guest guest]

Shamed Glaxo reveals research

Beezy Marsh and Tim Utton, Daily Mail

15 June 2004

BRITAIN'S biggest drugs firm caved in dramatically yesterday and

revealed research which shows a leading anti-depressant can cause

children to attempt suicide.

In an astonishing U-turn,

GlaxoKline 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.

Other stories:

King warns of house price crash

M & S: funds point to Green failure

Market report: Tuesday 14.00

Oil prices hike inflation to 1.5%

Brown longest-serving Chancellor

First-time homebuyers wary

Exel poised for Tibbett bid

Bundesbank 'homes for executives'

People urged to shop benefit frauds

Colleague grabbed my thigh - banker

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 £2bn 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 US 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 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 Glaxo 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 secret studies and what they found

BETWEEN 1993 and 2003, Glaxo-Kline 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 the US 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

US 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

US 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

US, 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

US 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.

[Guest guest]

Shamed Glaxo reveals research

Beezy Marsh and Tim Utton, Daily Mail

15 June 2004

BRITAIN'S biggest drugs firm caved in dramatically yesterday and

revealed research which shows a leading anti-depressant can cause

children to attempt suicide.

In an astonishing U-turn,

GlaxoKline 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.

Other stories:

King warns of house price crash

M & S: funds point to Green failure

Market report: Tuesday 14.00

Oil prices hike inflation to 1.5%

Brown longest-serving Chancellor

First-time homebuyers wary

Exel poised for Tibbett bid

Bundesbank 'homes for executives'

People urged to shop benefit frauds

Colleague grabbed my thigh - banker

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 £2bn 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 US 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 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 Glaxo 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 secret studies and what they found

BETWEEN 1993 and 2003, Glaxo-Kline 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 the US 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

US 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

US 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

US, 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

US 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.

[Guest guest]

Shamed Glaxo reveals research

Beezy Marsh and Tim Utton, Daily Mail

15 June 2004

BRITAIN'S biggest drugs firm caved in dramatically yesterday and

revealed research which shows a leading anti-depressant can cause

children to attempt suicide.

In an astonishing U-turn,

GlaxoKline 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.

Other stories:

King warns of house price crash

M & S: funds point to Green failure

Market report: Tuesday 14.00

Oil prices hike inflation to 1.5%

Brown longest-serving Chancellor

First-time homebuyers wary

Exel poised for Tibbett bid

Bundesbank 'homes for executives'

People urged to shop benefit frauds

Colleague grabbed my thigh - banker

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 £2bn 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 US 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 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 Glaxo 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 secret studies and what they found

BETWEEN 1993 and 2003, Glaxo-Kline 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 the US 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

US 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

US 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

US, 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

US 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.