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.
Sent Fri Oct 11, 2002
The manufacturer of the worldís best selling antidepressant, GlaxoSmithKline, has been ruled in breach of the pharmaceutical industry ís own code of marketing practice for misleading promotion of the drug in the UK. Essentially the issue addressed in the complaint is the company’s denial that the drug is addictive, causing many patients difficulty in withdrawing from Seroxat– as well as the other selective serotonin reuptake inhibitors (SSRI).
The ruling comes as a result of complaints made by the London-based health consumer group, Social Audit Ltd. The company (GlascoSmithKline) 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 Authorityís Appeal Board upheld Social Auditís complaints under the following provisions of the Code:
ìInformation, 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.î (ABPI Code, clause 7.2)
ìInformation 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 ësafeí must not be used without qualification.î (ABPI Code, clause 7.9)
ìInformation about medicines made available to the public … must be Ö presented in a balanced way Ö and must not Ö be misleading with respect to the safety of the productî (ABPI Code, clause 20.2)
The Appeal Boardís detailed findings will be published at a later date. Meanwhile, the basic documentation on the detail of the complaints and the companyís 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 ñ 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.
When will the FDA protect the American public by requiring drug manufacturers to fully disclose the known adverse side effects of these drugs?
The Secrets of Seroxat
Seroxat is one of the world’s biggest selling and most successful anti-depressants.
But this Panorama investigation discovers the drug may have a darker side – the programme claims that people can get hooked on it, suffering serious withdrawal symptoms when they try to come off it.
For some it can lead to self harm and even suicide. But little warning of these possible side effects accompanies the drug.
These are accusations that the drug’s maker Glaxo SmithKline denies.
The programme follows one Seroxat user and charts her nine month struggle to wean herself off it.
Panorama also spoke to Dr David Healy, an expert on the drug who has had access to confidential Seroxat studies in the Glaxo SmithKline archives.
Panorama: The Secrets of Seroxat will be shown on BBC One on Sunday 13 October at 2215BST
Production team: Reporter: Shelley Jofre Producer: Ed Harriman Assistant Producer: Sarah O’Connell Assistant Producer: Calum Walker Editor: Mike Robinson”