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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