Glaxo faces storm over Seroxat (Paxil)

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LONDON

09/06/03 - Business section

 

Glaxo faces storm over Seroxat

Alex Brummer, City Editor, Daily Mail

 

 

CLINICAL auditors from Britain's medicines control agency are expected to

descend on Glaxo-SmithKline this week amid concerns that the pharmaceuticals

group may have suppressed a series of negative studies on its key

antidepressant drug Seroxat, known as Paxil in the US.

 

In a highly unusual move, a team from the Good Clinical Practice unit of the

Medicines and Healthcare Products Regulatory Agency (MHRA) will demand

access to all of GSK's files and studies on Seroxat.

 

The decision to take this dramatic step was taken following the delivery to

the MHRA of nine studies of Seroxat that confirm the antidepressant can lead

to suicidal tendencies and other medical damage when administered to people

under the age of 18.

 

There has been extensive media coverage of the potential harmful effects on

young people of Seroxat, one of GSK's leading compounds. But until now the

company has declined to acknowledge any serious problems.

 

This week, however, it will be asked by the MHRA to contact general

practitioners, letting them know of the potential dangers to people under

18.

 

Sources at GSK confirmed that an amendment to the instructions carried with

Seroxat was under discussion with the authorities and an announcement would

be made shortly. There was no knowledge of the impending clinical audit.

 

Disclosure of the regulatory concerns about Seroxat, which contributes

£1.5bn-£2bn of annual turnover to GSK, is likely to lead to nervous selling

on the stock market when it opens for business today. Glaxo shares have

recovered to 1258p this year after falling below £10 in 2002.

 

Concerns that clinical practices may have slipped at Britain's flagship

pharmaceuticals group will put additional pressure on the company's chief

executive Jean-Pierre Garnier, who is already under fire over his possible

£22m severance package.

 

A senior source at the MHRA told the Daily Mail that the decision to conduct

an audit at GSK was 'very, very unusual'. 'Normally we have a good

relationship with these guys and work closely together,' the source said.

 

If it were found that critical studies had not been available to regulators

then GSK could eventually face criminal charges under the Medicines Act.

 

Previous Good Clinical Practice audits have been carried out at second-line

pharmaceutical groups where research practices are sometimes less rigorous.

 

Members of the Committee on the Safety of Medicines, the licensing arm of

the MHRA, were disturbed when they saw the parallel Seroxat and placebo

studies recently submitted by GSK. They revealed a predilection to suicide,

aggressive behaviour and other psychosis in Seroxat users under 18, which

were not present in the placebo studies.

 

The belief is that a deep volume of research work showing 'contraindications

in children' could not have been carried out overnight and the appropriate

regulatory authorities should have been alerted much earlier - so

appropriate amendments could be made.

 

The big worry for GSK now is that the disclosure of the disquiet at the MHRA

and its offshoots could attract the attention of the Food & Drugs

Administration in the US, which works closely with the British regulators.

 

That could seriously damage GSK's reputation in the US, where it does much

of its business and where Garnier has his headquarters.

 

A spokesman for GSK said: 'We can confirm we are in discussion with the MHRA

regarding proposed updates of the product characteristics of Seroxat.

However, it is not appropriate to discuss this dialogue further until the

outcome of this review.

 

'Seroxat is an important medication for treatment of anxiety and depression,

and has been for more than 10 years. It has benefited the lives of millions

of people suffering with these serious conditions.'

 

A decision on the safety of Seroxat/Paxil, and other widely prescribed

anti-depressants like Eli Lilly & Co's Prozac, will be announced tomorrow,

according to the UK Medicines Control Agency. 'We will be making an

announcement about Seroxat tomorrow but we're not saying anything in

advance,' spokeswoman Alison Langley said.

 

Glaxo refused to comment on whether a clinical audit was being carried out,

but confirmed it is in talks with the MHRA. 'We can confirm we are in

discussion with the MHRA regarding proposed updates of the product

characteristics of Seroxat,' Glaxo's Martin Sutton said.

 

.. SEROXAT is one of the biggest selling antidepressants in the world. It

treats depression, panic, obsessive compulsive disorder, post-traumatic

stress disorder, social anxiety disorder and general anxiety disorder. Last

year 400,000 people were prescribed the treatment, also known as the

'anti-shyness pill', in Britain alone.

 

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