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A moment of reverence for all who died, all who suffered from Paxil....

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Dear Friends and Associates,

Paxil is down. Let us now focus on Eli Lilly, Pfizer and the others. Take

time to celebrate this victory, but let us not forget there are others

waiting for justice to wield her mighty sword...

Cassandra Dawn

A.S.P.I.R.E.

** Note: Thus far, Lilly has avoided all responsibility... **

http://www.dailymail.co.uk/pages/live/articles/health/thehealthnews.html?in_arti\

cle_id=306667 & in_page_id=1797 & in_a_source=

Shamed Glaxo's u-turn on 'suicide' drug

by BEEZY MARSH and TIM UTTON,

Daily Mail 08:49am

15th June 2004

Britain's biggest drugs firm has caved in dramatically and revealed research

which shows a leading anti-depressant can cause children to attempt suicide.

In an astonishing u-turn, Glaxo-Kline 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.

Damning findings

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 £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

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.

'Suicidal thinking'

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.

Too little too late

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

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. "

===============================================================================

Debate: Should doctors be prescribing anti-depressants to teenagers?

http://chat.dailymail.co.uk/dailymail/threadnonInd.jsp?forum=119 & thread=9642135

Report: Agency blamed for promoting Seroxat

http://www.dailymail.co.uk/pages/live/articles/health/thehealthnews.html?in_arti\

cle_id=180011 & in_page_id=1797

News: Seroxat ban for children

http://www.dailymail.co.uk/pages/live/articles/health/thehealthnews.html?in_arti\

cle_id=184196 & in_page_id=1797

Article: Man slashed wrists on Seroxat

http://www.dailymail.co.uk/pages/live/articles/health/thehealthnews.html?in_arti\

cle_id=171852 & in_page_id=1797

Report: Seroxat warning to under-18s

http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=1842\

66 & in_page_id=1770

Link to comment
Share on other sites

Guest guest

Dear Friends and Associates,

Paxil is down. Let us now focus on Eli Lilly, Pfizer and the others. Take

time to celebrate this victory, but let us not forget there are others

waiting for justice to wield her mighty sword...

Cassandra Dawn

A.S.P.I.R.E.

** Note: Thus far, Lilly has avoided all responsibility... **

http://www.dailymail.co.uk/pages/live/articles/health/thehealthnews.html?in_arti\

cle_id=306667 & in_page_id=1797 & in_a_source=

Shamed Glaxo's u-turn on 'suicide' drug

by BEEZY MARSH and TIM UTTON,

Daily Mail 08:49am

15th June 2004

Britain's biggest drugs firm has caved in dramatically and revealed research

which shows a leading anti-depressant can cause children to attempt suicide.

In an astonishing u-turn, Glaxo-Kline 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.

Damning findings

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 £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

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.

'Suicidal thinking'

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.

Too little too late

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

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. "

===============================================================================

Debate: Should doctors be prescribing anti-depressants to teenagers?

http://chat.dailymail.co.uk/dailymail/threadnonInd.jsp?forum=119 & thread=9642135

Report: Agency blamed for promoting Seroxat

http://www.dailymail.co.uk/pages/live/articles/health/thehealthnews.html?in_arti\

cle_id=180011 & in_page_id=1797

News: Seroxat ban for children

http://www.dailymail.co.uk/pages/live/articles/health/thehealthnews.html?in_arti\

cle_id=184196 & in_page_id=1797

Article: Man slashed wrists on Seroxat

http://www.dailymail.co.uk/pages/live/articles/health/thehealthnews.html?in_arti\

cle_id=171852 & in_page_id=1797

Report: Seroxat warning to under-18s

http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=1842\

66 & in_page_id=1770

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