Not sure where I found this article - maybe in this newsgroup, but I think
it's worth posting (even if again):
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, GlaxoSmithKline finally published full details of
nine scientific studies and two clinical reviews which expose the dangers
posed to under-18s who take Seroxat (aka Paxil)
Children on Seroxat/Paxil 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 ₤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 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 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 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.
--
Sincerely,
Jonathan M. "TacticalSniper" Boyko
SWAT@GMX.Co.UK
TacticalSniper@Xaker.RU
JMTSB@BezeqInt.Net
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"E Pluribus Unum"
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