[SSRI-Research] Shamed Glaxo's u-turn on 'suicide' drug

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Wed, 16 Jun 2004 03:01:58 -0000

[sSRI-Research] Shamed Glaxo's u-turn on 'suicide' drug

 

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-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.

 

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 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

 

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. "

 

This story first appeared in the . For more great stories like this,

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