GSK spokesman broke ABPI code by issuing misleading statements about
Seroxat side effects
GlaxoSmithKline Plc breached the pharmaceutical industry’s code
of practice by downplaying the side effects of Seroxat (paroxetine).
A Prescription Medicines Code of Practice Authority appeal board upheld
three complaints against GSK from Social Audit, an organisation that campaigns
on behalf of the public interest in medicines where it believes this is
not being upheld.
Statements made to the press by a GSK spokesman were ruled to have breached
a clause of the code which requires information about medicines to be
accurate, balanced, fair, objective, based on an up-to-date evaluation
of available evidence and not to be misleading. The company was also ruled
to have breached clauses requiring information about side effects to reflect
available evidence, not to claim that a medicine has no side effects,
toxic hazards or risk of addiction, and to present information to the
public in a balanced way which does not mislead.
Following the ruling, Mr Charles Medawar, director of Social Audit, said:
“This is an important ruling which casts serious doubt on GSK’s
claims that paroxetine is not addictive or habit forming.” He also
criticised Seroxat’s patient information leaflet (PIL) saying that
the regulatory authorities should “fundamentally rethink” their
policies on warnings about medicines safety.
A spokesman for GSK said: “The rulings for the breach have not yet
been made clear to both parties. This is a case of two statements to two
journals, one in October 2001 and the other in April 2002. We can confirm
that the appeal has gone against us and we are obviously very disappointed.
However, we have taken steps to learn from this.
“We always strive for the highest standards of accuracy and honesty,
based on facts and data, in our communications about our products. This
is reflected in our patient information leaflet and summary of product
characteristics. These clearly detail that withdrawal symptoms may occur
in some patients but Seroxat is not addictive. The contents of the PIL
and SPC are approved by regulatory authorities.”
For the PCMPA Heather Simmonds said that no judgment had been made regarding
any statements included in the SPC or PIL for Seroxat. She said that these
were approved by the regulatory authorities and that insofar as they were
not promotional in nature were not subject to the provisions of the code.
The code of practice appeal board had considered complaints about statements
to the media concerning Seroxat which had been made by a GSK spokesman.
She confirmed that detailed reasons for the rulings had not yet been sent
to Social Audit or to GSK.
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