----- Original Message -----
From: Goldfinch, Richard
Sent: Tuesday, February 13, 2007 3:43 PM
Subject: RE: Communications Directorate
Dear Mr Fiddaman
I attach a copy of the MHRA complaints procedure. If you don't want to email email@example.com, you should send by post:
Very Well. I shall make a formal complaint via yourself in this email.
As you are aware I have been making various FOI requests to the MHRA over the past two years or so - the last, FOI 07/002 was answered by Tim Berridge, a copy of his answer was also sent to you and two others, namely, Muriel Passmore and Ingrid Calvert. None of my previous requests have ever been 'CC'd' to Muriel Passmore and Ingrid Calvert and I would firstly, like to know why these steps were taken, secondly, I would like to know whom these people are and thirdly, I would like to know why Mr Tim Berridge refuses to answer any of the follow-up questions I put to him about FOI 07/002
This is merely part of my complaint regarding FOI 07/002.
I asked three questions, two of which were answered, the third was 'shelved' under the exemption rule contained in the FOIA, section 21.
It took 20 working days exactly to answer two questions, I find this totally unacceptable, you may remember Mr Goldfinch I had to write you twice to remind you?
Anyway, to the crux of the problem I have with the answers of Mr Tim Berridge and his lack of communication at my follow-up questions.
1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?
Mr Berridge 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?
Mr Berridge 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."
Finally, Mr Goldfinch
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.
The reccomendation I recieved from Mr Berridge after he threw the exemption rule Section 21 at me was laughable.
Answer: Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available. The information you have requested concerning the 'correcting effect’ is subject to the exemption contained in the FOIA, namely Section 21 - 'information accessible to the applicant by other means.' The trials conducted by GSK on paroxetine can be found on their website (http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp).
Here we have a company, Glaxo SmithKline, who are currently under investigation by the MHRA regarding Seroxat and a member of the MHRA refers me to thier webpage to read about the very same trials that are being investigated by the MHRA!
At first I had to double check - was I hallucinating? Did I just read that?
You have to admit Mr Goldfinch, to point me to the very same company you are investigating borders on the absurd. I do not believe Glaxo SmithKline have published ALL the trial data and certainly not the negative trial data. Both you and I know that Glaxo SmithKline have witheld information from the public to booster sales of Seroxat, they have done this without a care for the health and safety of patients... worse still Mr Goldfinch, the MHRA, the very same body put into action to stop this sort of behaviour have stood by and let them do it!
You will no doubt throw yet another exemption rule at me regarding this current investigation. Three years Mr Goldfinch... three long years and still Glaxo SmithKline manufacture and sell Seroxat. One only has to Google the word 'SEROXAT' to be faced with horror story after horror story about the patients the MHRA has allowed to suffer. You need to pull out all the stops to end this investigation Mr Goldfinch. You have a suspect and you take three years? - if our Police force acted the way the MHRA did then we would have murderers running amok on the streets of Britain.
Please answer my questions, I have a right to know. Glaxo SmithKline have peddled Seroxat for many years despite the thousands, probably millions worldwide, of horror stories of children and adults.
BBC recently ran a programme about Seroxat, their fourth one! Does this not tell the MHRA that there is something drastically wrong within the walls of GSK?
With two former employees of GSK working for the MHRA I suspect you may personally find it 'difficult' to give an honest answer.
So, there you have it Mr Goldfinch - in a nutshell I am sick and tired of the lack of transparency the MHRA are showing me - I am exhausted but will not surrender and will continue to campaign and help others who have struggled... and still are... with Seroxat.
You may gloss over my rant about the ongoing investigation but please do not ignore the questions I have put to you regarding the answers I recieved from Mr Tim Berridge and please do not tell me whether or not I can relay information I have recieved regarding a FOI request to other people. This matter is of public interest so in future do not add any copyright notice in future correspondence to me.
I look forward to your reply but suspect I shall once again be stonewalled by the MHRA
Mr Robert Fiddaman