Decoding Psychiatric Propaganda
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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.

http://www.thisislondon.co.uk/news/business/articles/timid79389?source

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Decoding Psychiatric Propaganda
http://groups.msn.com/psychbusters