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(U.K.) [Paxil/Seroxat] Revealed: secret plan to push'happy' pills

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Fri, 12 Nov 2004 19:08:00 -0500

[sSRI-Research] [Paxil/Seroxat] Revealed: secret plan to

push'happy' pills

 

The Guardian

 

Revealed: secret plan to push'happy' pills

 

· MPs probe drugs giant's bid to boost Seroxat

· Fears over new targets for anti-depressant

 

http://observer.guardian.co.uk/uk_news/story/0,6903,1345512,00.html

 

Jamie Doward and Robin McKie

Sunday November 7, 2004

The Observer

 

Britain's largest drug company drew up a secret plan to double sales

of the

controversial anti-depressant Seroxat by marketing it as a cure for a raft

of less serious mental conditions, The Observer can reveal today.

 

The contents of the 250-page document have alarmed health campaigners who

accuse the firm, GlaxoSmithKline (GSK), of putting profit before the

therapeutic needs of patients by attempting to broaden the market for the

drug which has been linked to a spate of suicides.

 

The revelation is likely to prompt further concerns about the role and

influence of the pharmaceutical industry, which has come under severe

scrutiny in recent months. The document is now being investigated by a

parliamentary inquiry into the drugs industry.

 

The internal report carries a section which outlines how GSK planned to

double sales of 'selective serotonin reuptake inhibitors (SSRI)' - the

industry term for anti-depressants - by winning the marketing war against

Seroxat's chief rival, Prozac, manufacured by Eli Lilly.

 

Written in 1998 and subsequently updated in following years, the

section is

entitled: 'Towards the second billion - all SSRIs are not the same' and

discusses strategies to see off the threat posed by Prozac.

 

The document outlined how GSK intended to market Seroxat for a range of

conditions other than clinical depression. Chief among these was a

condition

the company identified as social anxiety disorder, although other forms of

anxiety were also discussed internally.

 

'What this document makes clear is that a number of different forms of

anxiety were being targeted in a systematic way. The thrust was to move

sales beyond the $1 billion to $2 billion mark by pushing it to people who

were not clinically depressed,' said Professor David Healy, a

psycho-pharmacologist at Cardiff University, who has given evidence to the

House of Commons Health Select Committee.

 

Richard Brook, chief executive of Mind, the mental health charity which

submitted the document to the committee, told the MPs it was 'all about

developing new conditions for that drug and demolishing the arguments of

other competitors about why their drug was not any good'.

 

In addition the document shows GSK made a great virtue of the fact that

Seroxat had a relatively short 'half-life' compared with Prozac, an

argument

which has subsequently proven deeply controversial.

 

A half-life is the scientific term for how long it takes for the

concentration of a drug to drop by 50 per cent in a patient's bloodstream.

The company suggested Seroxat's short half-life meant patients could

come on

and off the drug easily, compared with those on Prozac, even to the extent

that they could take 'treatment holidays'. 'There was an argument that a

short half life was really good news,' Brook said.

 

'But five years later, Seroxat has withdrawal issues. It's the short half

life that causes the problems. The substances get into the body so quickly

it causes some sort of dependency reaction. So one of the things the

company

was saying was a benefit was actually a problem.'

 

In its submission to the parliamentary committee Mind said the original

trial data submitted to the UK regulators by GSK showed the claim was at

best 'naive and at worst seriously mislead ing'. It added that 'the

Seroxat

file is highly illustrative of using marketing information as facts'.

 

Concerns about the addictive properties of Seroxat saw the government ban

its prescription to people under the age of 18 last year. This followed a

review which found children taking it were more likely to self-harm or

commit suicide.

 

A spokesman for GSK said Seroxat could be marketed at new conditions only

after stringent testing. 'Medical authorities around the world have

required

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

condition specifically.'

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