- Britain's largest drug company drew up a secret plan
to double sales of the controversial anti-depressant Seroxat [Paxil in
the US] by marketing it as a cure for a raft of less serious mental conditions,
The Observer can reveal today.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- '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.
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- 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'.
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- 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.
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- 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.
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- '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.'
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- 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'.
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- 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.
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- 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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- SocietyGuardian.co.uk © Guardian Newspapers Limited
2004 http://society.guardian.co.uk/mentalhealth/story/0,8150,1345565,00.html
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