Glaxo Reveals Truth on 'Suicide'
Daily Mail; London (UK)
biggest drugs firm caved in dramatically yesterday
and revealed research which shows a leading
antidepressant can cause children to attempt
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
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
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 authorities here are investigating
whether Glaxo complied with legal requirements to
make all relevant clinical trial data on the drug
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
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
'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
'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
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
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
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
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
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
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
The study also failed to find any evidence that
Seroxat was more effective than placebo in
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
Study 676 U.S., Canada, Belgium, South Africa.
319 patients aged eight to 17. Serious
side-effects in three on Seroxat, compared to one
Nine on Seroxat had to drop out of the study as
a result of side- effects, compared to two on
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
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.