[e-drug] GSK found in breach of ABPI code

[charles@socialaudit.org.uk]

E-DRUG: GSK found in breach of ABPI code
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[WB]

SOCIAL AUDIT COMPLAINTS AGAINST GLAXOSMITHKLINE UPHELD - RE: PROMOTION OF
PAROXETINE (Seroxat, Paxil etc)

The manufacturer of the world's best selling antidepressant,
GlaxoSmithKline, has been ruled in breach of the pharmaceutical industry's
own code of marketing practice for misleading promotion of the drug,
Seroxat (paroxetine) in the UK. This product, Seroxat (known as Paxil in
the USA) is the subject of a major BBC-TV documentary (Panorama), to be
shown on Sunday, 13 October 2002.

Following complaints made by the London-based health consumer group, Social
Audit Ltd, the company (GSK) was judged in breach of three clauses of the
marketing code of the Prescriptions Medicines Code of Practice Authority
(PMCOPA), the semi-autonomous self-regulatory scheme operating under the
aegis of the Association of the British Pharmaceutical Industry (ABPI).
Following a three-hour hearing on October 10th, The Authority's Appeal
Board upheld Social Audit's complaints under the following provisions of
the Code:

"Information, claims and comparisons must be accurate, balanced, fair,
objective and unambiguous and must be based on an up-to-date evaluation of
all evidence and reflect that evidence clearly. They must not mislead
either directly or by implication." (ABPI Code, clause 7.2)
"Information and claims about side-effects must reflect available clinical
evidence or be capable of substantiation by clinical experience. It must
not be stated that a product has no side effects, toxic hazards or risks of
addiction. The word 'safe' must not be used without qualification." (ABPI
Code, clause 7.9)
"Information about medicines made available to the public ... must be .
presented in a balanced way . and must not . be misleading with respect to
the safety of the product" (ABPI Code, clause 20.2)

Social Audit had another complaint upheld about GSK's promotion of
paroxetine (Paxil) one year ago. On both that and this occasion, the
complaint was originally rejected - but then won on Appeal. The Appeal is
heard by a board comprising 12 members from the pharmaceutical industry and
6 independent members, including the Chairman (Mr Nicholas Browne QC). One
member of the Appeal Board (Mrs Mary Baker MBE) represents patient's
interests.

The complaints were brought by Mr Charles Medawar, Director of Social Audit
Ltd. Three other experts attended the Appeal helped to present Social Audit
's case. They were: Dr Andrew Herxheimer (Emeritus Follow, The Cochrane
Centres, and founder editor of Drug & Therapeutics Bulletin); Dr David
Healy (Consultant psychiatrist and psychopharmacologist, historian of
psychiatry); Ms Anne Winyard (Solicitor with Leigh Day & Co, acting
pro-bono publico). Following news of the ruling by the PMCOPA, Mr Medawar
said:

"This is an important ruling which casts serious doubt on GSK's claims that
paroxetine is not addictive or habit forming - and by extension applies to
all manufacturers of antidepressant drugs of this kind. It also discredits
the regulatory response to the problem of severe withdrawal reactions on
antidepressants - and raises basic questions about the effectiveness of
such drugs in long-term use. This ruling should cause the UK Committee on
Safety of Medicines/Medicines Control Agency, the US Food & Drug
Administration and the European Medicines Evaluation Agency, to
fundamentally rethink their warnings policies - which to date have been
lamentable.

The absurdity of the UK regulators' position is underlined by the PMCOPA's
ruling that GSK was in breach of Clause 7.9, which says that manufacturers
should not claim a drug carries no risk of addiction - because the current
Patient Information Leaflet, approved by the MCA/CSM, positively emphasises
just that: "These tablets are not addictive" . "remember that you cannot
become addicted to 'Seroxat'", and that the withdrawal symptoms some people
experience when stopping paroxetine "are not common and (they) are not a
sign of addiction".

Social Audit's allegations are set out in detail in the correspondence
shown below. Briefly, Social Audit's had complained that, in promoting
paroxetine (Seroxat/Paxil) GlaxoSmithKline had consistently understated the
risk of withdrawal reactions and dependence, obfuscating the truth by using
definitions and terms wholly unfamiliar to consumers and probably many
doctors as well.  Social Audit argued that GSK should be using terminology
consistent with the central idea in World Health Organisation statements:

"The simplest definition of drug dependence given by WHO (1994) is 'a need
for repeated doses of the drug to feel good or to avoid feeling bad.' When
the patient needs to take repeated doses of the drug to avoid bad feelings
caused by withdrawal reactions, the person is dependent on the drug." (WHO,
Lexicon of alcohol and drug terms, 1994, and  WHO bulletin, Drug
Information, 1998, 12, 3, 136-138.)

Social Audit accused GSK of inviting patients to infer that the government
enquiries had established there was no risk of dependence when this was not
true. In fact, the jury is still out - and it is misleading to represent a
tentative verdict of 'non-proven' as 'not guilty'. The continuing risk is
underlined by the recent announcement by the UK regulators (responding to a
request from Social Audit) that the Committee on Safety of Medicines will
conduct a further review of SSRI dependence at its meeting on 21 November.

This PMCOPA Appeal Board rejected Social Audit's complaints under Clause
3.2, a decision Medawar described as "inexplicable - other than as a
reflection on the pitiful state of government regulation". This clause in
effect says that promotional materials should be in line with the
information made available to health professionals (in the data sheet or
Summary of Product Characteristics) and to consumers (in the Patient
Information Leaflet):

"The promotion of a medicine must be in accordance with the terms of the
marketing authorization and must not be inconsistent with the particulars
listed in its summary of product characteristics" (Clause 3.2)

Mr Medawar said that the Appeal Board had "ample evidence before it of
several breaches of this requirement", including a letter to Social Audit
from Dr June Raine of the Medicines Control Agency, confirming that
persistent misdescription of drug "withdrawal symptoms" as "discontinuation
symptoms" was inconsistent with both UK and European regulatory
requirements. Medawar confirmed that Social Audit would be writing to the
Medicines Control Agency asking them to take action against GlaxoSmithKline
"in relation to this and several other obvious violations" and to advise
the PMCOPA accordingly.

Social Audit had also sought a judgment against GSK for a breach of Clause
2 of the ABPI Code: " . promotion must never be such as to bring discredit
upon, or reduce confidence in, the pharmaceutical industry" Mr Medawar
said, "We believe GlaxoSmithKline has behaved disgracefully, causing many
patients much distress. It is hard to imagine what more a company needs to
do to be in breach of this requirement - though we knew our chances were
slim, since 'a ruling of a breach of this clause is a particular sign of
censure and is reserved for such circumstances'."  Medawar added:

"it's pretty depressing to learn that the other companies represented on
the Appeal Board consider that public confidence in  GSK's would not be
badly shaken. True, this would have been a very hard decision for the
Appeal Board - though I expect that, with further disclosure and in time,
they will come to regret they could not rise to this occasion"

The Appeal Board's detailed findings will be published at a later date.
Meanwhile, the basic documentation on the detail of the complaints and the
company's response has been posted on the Social Audit website at
www.socialaudit.org.uk. The Social Audit website now attracts over 250,000
visitors/year - and includes well over 1,000 messages from disappointed and
often very distressed users of paroxetine and similar drugs. The Social
Audit website is one of several websites dedicated to reporting evidence
not only of the benefits, but also the risks of antidepressant drugs.

Relevant documents will shortly to be posted on the Social Audit website:
http://www.socialaudit.org.uk

Further information

Charles Medawar, mail@socialaudit.org.uk and +44 (0)20 7586 7771
Dr David Healy, healy_hergest@compuserve.com and 01248 384452
Dr Herxheimer, Andrew_Herxheimer@compuserve.com and 020 8346 5470
Anne Winyard, AWinyard@leighday.co.uk and 020 7650 1200

Also
Mrs Heather Simmonds, Director, Prescription Medicines Code of Practice
Authority (020 7930 9677);
Mr Eddie Gray, GlaxoSmithKline, (020 8990 9000)

Charles Medawar
Social Audit Ltd
P.O. Box 111
London NW1 8XG   UK
TEL/FAX +44 (0)20 7586 7771
charles@socialaudit.org.uk
http://www.socialaudit.org.uk


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