Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, February 27, 2008

GSK hits back over 'alarmist' antidepressant analysis

Well you didn't expect them to actually admit it now did you?

They have a history of admitting no liability so why change?

The statement can be read at Pharma Times.

Keeping with GSK tradition I'd like to summarise it for you - as they do with their clinical trial results. Hope you don't mind Glaxo - I mean, what's good for the goose eh?

GSK “believe that it has caused unnecessary alarm and concern for patients”.
Hmmm. Great let's put the onus on the patients. Let's spin this on its head to show the patients that we really care about their fears. Have GSK EVER listened to their patients?

...antidepressants “remain an important option, in addition to counselling and lifestyle changes, for patients suffering from depression”.
But GSK know that counselling costs money, money that this government are not prepared to offer up. Sure, promises were made yesterday as UK Health Secretary Alan Johnson unveiled plans for a major new programme to train an extra 3,600 psychological therapists. But actions speak louder than words.

“we strongly believe that the authors’ interpretation is incorrect and is clearly at odds with the benefits of antidepressants routinely observed in actual clinical practice”.
This is a little gem isn't it? You notice how they use the term 'antidepressants' and NOT 'Seroxat'? Tell me, What are the benefits of Seroxat? I bet you I can give you at least 10 risks to one benefit! Here's nearly 10,000 people that disagree with you.

“regulatory bodies around the world have conducted extensive reviews of published and unpublished data for licensed antidepressants and have concluded that these medicines provide benefit to patients”.
There's that word again, 'benefit' - and why the omission once more of the word 'Seroxat'? The truth is GSK, you are being investigated for not submitting published and unpublished data to the very same people you claim have conducted extensive reviews. Extensive reviews of the data you provided them maybe - but we all know the data you DO NOT give them clearly shows that your drug (in this case, Seroxat) is defective. And while we are on the subject, the Medicines Regulator here in the UK have been less than satisfactory when reviewing data. One only has to look at the MMR/Autism debacle (SEE PART E HERE)- They messed up then and they have clearly messed up again regarding Seroxat... and will continue to do so as long as there is a conflict of interest, ie; Alisdair Breckenridge & Ian Hudson - you remember them don't you Glaxo? Sure you do - they now work for the MHRA - Can you ever remember them working for you?

GSK says that “contrary to what has been reported”, the study has only examined a small subset of the total data available for antidepressants. With paroxetine for example, “this study only considers data from 16 trials out of a total database of more than 170 trials involving at least 14,000 patients”.
And did you offer all your data to the medicines regulator regarding Paxil Study 329? C'mon, we really can see right through you Glaxo.

With regards to Paxil, “all trial data published and unpublished were submitted to regulators, at the time of registration”, GSK notes, saying that all the data related to paroxetine, “regardless of study outcome”, are available at the company’s clinical trials register on its website.
Well, we know that's a lie. Glenmullen's report shows that it is as does Breggin's report from 2001. Tell me Glaxo, why are the MHRA currently investigating you?

“rejects any suggestion that we deliberately withheld data on paroxetine”
SEE HERE, HERE & HERE

In addition, however, GSK responded to a request for data on the use of paroxetine in children. The spokesperson noted that the company provided a list of the studies that had either been completed or were underway, “however this was an unlicensed indication and was subject to an ongoing regulatory review by the Medicines and Healthcare products Regulatory Agency. It was therefore not appropriate to provide these data to NICE ahead of the MHRA's conclusions."
So now a criminal investigation becomes a 'review'? As far as I am aware, the MHRA are investigating you! This is no review. If it is merely a review, it will probably be laden with errors.

Alison Cobb, treatments expert at mental health group Mind, said that the study “makes a serious challenge to the predominance of drugs in treating depression"

At last! someone with compassion!



Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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