[drugawareness] BBC Sunday - Secrets of Serosat [Paxil]

[Guest guest]

atracyphd wrote:

 

My Groups | drugawareness Main Page

 

 

Several of you have notified us that Seroxat (Paxil in the US) will be the

subject of a major BBC-TV documentary, airing Sunday, 13 October 2002.

 

Because Vera of the ALLIANCE FOR HUMAN RESEARCH PROTECTION

(AHRP) explains the situation so well I am going to forward her information on

this special to you.

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition for Drug Awareness (ICFDA)

www.drugawareness.org and author of Prozac: Panacea

or Pandora? (800-280-0730)

 

 

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 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 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)

 

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.

 

When will the FDA protect the American public by requiring drug manufacturers to

fully disclose the known adverse side effects of these drugs?

~~~~~~~~~~~~~~

 

http://news.bbc.co.uk/1/hi/programmes/panorama/2310197.stm

BBC

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 "