----- Original Message -----
From: fiddaman64
To: Berridge, Tim
Cc: Gisela
Sent: Tuesday, February 13, 2007 7:37 AM
Subject: Re: FOI 07/002
Dear Mr Berridge,
I would be grateful if you could answer my emails. I know you have read them as I have recieved a read reciept. Please have the courtesy to answer the follow up questions I have put to you regarding your answers to my FOI request 07/002. (Below) I am still astounded that you referred me to GSK's website to obtain the information I requested, particularly as they are supposed to be under investigation by the MHRA... and have been so for the past three years.
Please live up to your name and be 'transparent' with me.
Regards
Robert Fiddaman
----- Original Message -----
From: fiddaman64
To: Berridge, Tim
Cc: Gisela
Sent: Sunday, February 11, 2007 8:24 AM
Subject: Re: FOI 07/002
Dear Mr Berridge,
Is it your intention to answer the issues I raised regarding the answers I recieved regarding my FOI request 07/002? (See below)
----- Original Message -----
From: Berridge, Tim
To: fiddaman64
Cc: Passmore, Muriel ; Calvert, Ingrid ; Goldfinch, Richard
Sent: Wednesday, January 31, 2007 3:31 PM
Subject: FW: FOI 07/002
Dear Mr Fiddaman,
Please see attached response to your FOI request.
Kind regards
Mr Tim Berridge Licensing Division MHRA
Tel: 0207084 2391 Fax: 0207084 2170
Dear Mr Berridge,
Firstly I would like to thank you for your response, although why it took 20 working days to basically answer two questions still remains a mystery. I was also concerned to see that you had copied in three other people, Richard Goldfinch I know of but the other two, namely, Muriel Passmore and Ingrid Calvert, I cannot recollect ever seeing their names before in my correspondence with the MHRA. Could you tell me firstly, why these two were copied in on your email to me and secondly what division of the MHRA do they work in (if they work within the MHRA that is)
Now onto my Freedom of Information request and the answers provided by you.
I asked:
1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?
You replied:
Yes, a lot of this information has arisen from our knowledge of other antidepressants and from animal studies and animal models. To the best of my knowledge, this has never been directly proven in humans
I am glad to see we now have it on record that GSK did indeed provide the MHRA documents giving details about the imbalance of serotonin in the brain, I am somewhat confused though because to my knowledge, based purely on my own research, there is NO or never has been any scientific study into the imbalance of serotonin in the brain. The last line of your answer to question )1) you state 'To the best of my knowledge, this has never been directly proven in humans'. Now call me flippant or naive but what on earth are the MHRA doing granting a licence to GSK for a drug that they (GSK) claim, and I quote here from the Seroxat patient information leaflet "...People who are depressed or anxious have lower levels of serotonin than others." To make a broad statement like that surely must mean that there have been some 'human' experiments carried out by GSK regarding the imbalance of serotonin. Is this claim by GSK on the Seroxat patient information leaflet something the MHRA have overlooked or do the MHRA actually agree with GSK that people who are depressed or anxious have lower levels of serotonin than others?
Moving on to question (2) of my Freedom of Information request:
2. Did GSK provide the MHRA documents with figures for the effect the drug had in changing the imbalanced state?
You replied:
No. To my knowledge, it would not be possible to conduct such a trial in humans.
Once again I bring to your attention the Seroxat patient information leaflet that states "...People who are depressed or anxious have lower levels of serotonin than others."
Could you or any other expert tell me how GlaxoSmithKline arrived at this assumption bearing in mind that, in your own words Mr Berridge, you told me '...it would not be possible to conduct such a trial in humans'
Thirdly, I approach question (3) and its answer by you with a sense of bewilderment.
I asked:
3. Please forward me documents that GSK supplied the MHRA during the application procedure for Seroxat that relate to the 'correcting effect' regarding people with lower levels of serotonin
Your reply was basically no answer, using instead the exemption rule contained in the FOIA, section 21 - Information accessible to the applicant by other means.
Whilst I have to accept this I was however totally flabbergasted that you suggest that I go to the website of GSK to read of the trials conducted by GSK on Paroxetine/Seroxat.
Flabbergasted because the MHRA are currently investigating GSK regarding the clinical trials of Paroxetine/Seroxat. I, as a member of the public, have grave concerns over anything that comes out of GSK, particularly their 'published' Seroxat clinical trial data.
Why then would someone from the MHRA direct me to a website of a company who are currently under investigation by the MHRA? It just defies belief and all logic.
Finally, a colleague of mine noticed that answers to FOI requests from the MHRA are now carrying a copyright notice at the foot of the response. Are you suggesting to me that whatever information I receive from you via the FOI should remain for my eyes only?
Like you, I have taken the liberty of copying in people in this email, some you or your peers will be aware of, others you will not. I trust I am not breaking any copyright rules here.
Regards
Mr Robert Fiddaman
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