Paxil: Violent Behavior Reported by One out of Five Paxil Users

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Sun, 7 Nov 2004 11:50:24 -0500

Subject:[sSRI-Research] Paxil: Violent Behavior Reported by One out of

Five Paxil Users

 

This article states: " A survey carried out by the mental health

charity Mind, in collaboration with Panorama, found that 97 per cent

of respondents knew of someone who had experienced unwanted or

uncomfortable reactions to Seroxat. These included: reduced sexual

desire, sleep problems, fatigue, irritability and sweating. One in

five reported violent behaviour. Half who had experienced a reaction

had feelings of self harm or suicide and more than four out of five

experienced withdrawal problems. "

 

" Then stories began to circulate about suicides and self-mutilation

and the Seroxat hype began to unravel. An internal GlaxoSmithKline

memo written in 1998 revealed that trials in children actually showed

it was no better than a placebo in alleviating depression. "

 

" A typical case that made tabloid headlines recently was that of

18-year-old Jamie Hoole who started taking Seroxat. He responded well

to his daily 20mg regime. But soon his depression returned. Jamie - a

promising musician - became increasingly anxious. He started to cut

his arms and legs. Finally he hung himself. The coroner at his inquest

said Jamie's death may have been 'wholly or in part' linked to Seroxat. "

 

http://observer.guardian.co.uk/uk_news/story/0,6903,1345437,00.html

 

 

Dark secrets lurking in the drugs cabinet

 

Seroxat was hailed as the wonder pill. Now it is at the centre of a

new controversy, report Jamie Doward and Robin McKie

 

Sunday November 7, 2004

The Observer

 

Hailed as one of the greatest additions to the medicine cabinet since

the invention of antibiotics, the antidepressant Seroxat has become a

symbol for all that is wrong and suspect about the pharmaceutical

industry today.

 

It was supposed to be a cure for most of the woes of the modern world,

a happy pill that would banish the misery of depression and gloom. Now

it is seen by an increasing number of campaigners, academics and

doctors as a dramatic illustration of our inability to control the

behaviour of drug companies. As evidence mounts about the uncontrolled

use of anti-depressants, pharmaceutical companies have responded

simply by trying to find new conditions they could market as targets

for these controversial drugs.

 

And while the government last week indicated it was considering plans

to break the close links with the pharmaceutical industry and the

nation's drug watchdog group, the Medicines and Healthcare products

Regulatory Agency (MHRA), many experts feel the move could be doomed

to failure, particularly when it comes to antidepressants and other

medicines for emotional problems.

 

'It would be good to get impartial advice but it is difficult in

practice for any academic in the field to gain expertise in drug

action without having to interact with the pharmaceutical industry,'

said Professor Til Wykes, director of the UK mental health research

network. 'That makes it very hard to avoid accusations of partiality.'

 

Seroxat and Prozac are the most widely used members of drugs called

SSRIs - selected serotonin re-uptake inhibitors. Studies suggest

serotonin plays a key role in affecting a person's emotions.

Increasing serotonin levels is considered an antidote to depression.

SSRIs act within the brain to do just that: increase serotonin levels.

 

 

Unlike most drugs, however, SSRIs were specifically designed - as

opposed to discovered - as a treatment for depression. Seroxat was

introduced 14 years ago. Apart from being an antidote to depression,

it would allow, it was claimed, hyperactive children to lead normal

lives, and stop those with obsessive-compulsive disorders from harming

themselves. It was also cheap and had only slight side effects, said

its makers.

 

Several million people were given the drug in Britain, including more

than 50,000 children. Everything seemed to go well - for a while.

 

Then stories began to circulate about suicides and self-mutilation and

the Seroxat hype began to unravel. An internal GlaxoSmithKline memo

written in 1998 revealed that trials in children actually showed it

was no better than a placebo in alleviating depression. 'It would be

commercially unacceptable to include a statement that the efficacy had

not been demonstrated, as this would undermine the profile (of the

drug),' the memo stated.

 

Worse, when the company examined the details of its trial data, it

found that more of the children on the real drug, compared with those

on a placebo, had suicidal thoughts. A typical case that made tabloid

headlines recently was that of 18-year-old Jamie Hoole who started

taking Seroxat. He responded well to his daily 20mg regime. But soon

his depression returned. Jamie - a promising musician - became

increasingly anxious. He started to cut his arms and legs. Finally he

hung himself. The coroner at his inquest said Jamie's death may have

been 'wholly or in part' linked to Seroxat.

 

'Jamie got worse and worse and it was frightening,' said his mother,

Jean. 'I thought the doctors would take him off it. They didn't. But

nobody has had the full facts before taking this drug. That makes me

angry.'

 

The issue is not that SSRIs are overwhelmingly deadly but that there

is a real danger in prescribing them for young people and emotionally

sensitive individuals. One US study, using UK data, revealed that

anti-depressants are linked to suicidal thoughts during the first few

weeks of their use, but that these effects wear off. In short, these

antidepressants can be helpful for some people but great care must be

taken in prescribing them, a point that appears not to have been

hammered home until very recently.

 

A survey carried out by the mental health charity Mind, in

collaboration with Panorama, found that 97 per cent of respondents

knew of someone who had experienced unwanted or uncomfortable

reactions to Seroxat. These included: reduced sexual desire, sleep

problems, fatigue, irritability and sweating. One in five reported

violent behaviour. Half who had experienced a reaction had feelings of

self harm or suicide and more than four out of five experienced

withdrawal problems.

 

These findings are backed by other studies which have also noted these

effects are far more pronounced in younger people. As a result the

MHRA finally issued guidance which outlawed the prescription of the

drug to under-18s. Last year European watchdogs also recommended extra

care be taken in prescribing Seroxat for people under 30.

 

Such advice flies in the face of pharmaceutical practice, however.

While health regulators are now becoming increasingly anxious to

control the use of Seroxat and other antidepressants, drug companies -

equally anxious to gain as much income as possible from their

medicinal cash cows - are trying to expand their uptake.

 

GlaxoSmithKline has made billions out of Seroxat and sees no reason

why this should halt, it would appear. One of its internal marketing

documents shows the company planned to double sales by targeting

people who suffer from a widely recognised condition known as social

phobias.

 

'But they changed the words,' said Professor David Healy, a

psychopharmacologist at Cardiff University. 'They called it social

anxiety disorders. Phobias imply a behaviour that can be treated by

therapy. Anxiety disorder implies it is more about drugs.'

 

In addition, GSK has marketed the drug as the answer for people who

suffer from post-traumatic stress disorder. Such projected uses are

far from those that were originally envisaged for the drug as a

general treatment for clinical depression.

 

This point is not denied by GSK, however. A spokesman told The

Observer that Seroxat could be marketed for new conditions but

insisted that this would only be done after stringent tests had been

carried out. 'Medical authorities around the world have required that

GSK study each condition separately in order to prove benefit in each

con dition specifically,' he said.

 

'With more than 13 years of safety and effectiveness data on Seroxat

that has been built from use by patients all over the world, as well

as clinical trials involving 24,000 patients, there are few medicines

that have been studied in as much detail. As with all important

medicines, Seroxat and other SSRI anti-depressants can cause side

effects in some people. Information about these is provided to doctors

and patients and is updated as we learn more from clinical trials and

the monitoring of patients world-wide.' He added: 'Seroxat is an

important medicine designed to treat serious psychiatric diseases.

These disorders can be severe, distressing, debilitating and

potentially deadly.'

 

Richard Brook, Mind's chief executive, writes in the latest issue of

the Journal Of Mental Health: 'The trouble is that pharmaceutical

companies form a massive part of the UK economy and have to survive in

a ruthless commercial environment. They exert a pervasive influence

over the research into and use of medicines. Virtually all research on

drugs - 70 per cent of trials reported in major medical journals - is

funded by the industry. Drug companies therefore have a hugely

disproportionate influence on what gets researched, and also how it is

researched, how the results are interpreted, and how - and crucially

whether - the results are reported.'

 

Among the accusations now levied against the drug firms are that they

'ghost'-write medical journal articles published by leading doctors,

sponsor conferences and other medical training events and pay large

fees to doctors to talk about their products.

 

'They have all the data on their new products and before any

independent person can get at the data it takes months or years, so

that inde pendent information limps a long way behind the commercially

driven information and is in a much lower volume,' said Dr Andrew

Herxheimer, founder of the Drug and Therapeutics Bulletin, in evidence

to the parliamentary select committee currently hearing evidence on

the influence of the pharmaceutical industry. 'The funding for that is

extremely small compared with the industrial funding of promotion; so

that creates an overwhelming imbalance.'

 

Nor is the problem helped by the nature of the MRHA. The agency is an

opaque organisation that has long been the target of campaigners who

accuse it of being completely funded by the pharmaceutical industry.

It is not, but the secrecy of its behaviour does not help. In contrast

with the FDA in the US it does not publish the results of its trials

on a publicly accessible website.

 

'You cannot get access to the good points or the hazards. They're

incredibly secretive,' Healy said. 'You could have experts having

close links, providing you can see what they say. Then we can make up

our own minds.'

 

Anti-depressants: Ups and downs

 

The World Health Organisation estimates that by 2020 depression will

be the second largest cause of death and disability in the world.

 

As many as one in three people will experience some form of depression

in their lifetime.

 

Global sales of anti-depressants total more than $17 billion, making

them the third best-selling class of drugs in the world.

 

Studies show 70 per cent of people who take anti-depressants start to

feel better after their first prescription.

 

Anti-depressants reduce the symptoms of depresssion which include loss

of interest, sleeping too much or too little and feelings of

worthlessness or excessive guilt.

 

Studies show between 30 and 40 percent of children and adolescents

with depression will not respond to an initial medication.

 

Long-term side effects of taking anti-depressants include sleep

disturbances, weight gain and sexual dysfunction.

 

Early side effects include nausea, diarrhoea, headaches and agitation.

These usually disappear within two to three weeks of taking the drugs.

 

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