E-mail correspondence between Social Audit and the MHRA


1 October 2006 – FOI  request to MHRA, by email

-----Original Message-----
From: [email protected]
[mailto:[email protected]]
Sent: 01 October 2006 09:02
To: FOI_request
Subject: FOI Website Request Sun Oct 01 09:02:00 BST 2006

This enquiry arises in connection with the response to my 'para 11'
queries sent to me by Ms Sarah Wark on 4 September 2006 (MHRA Ref

Please will you let me know [a] on what date (at which meeting) members
of the CSM Expert Working Group on SSRIs were supplied with copies of
summaries of individual case reports of the three placebo suicides
reported in paroxetine trials, and [b] to which of the "assessment
reports" she refers were these case summaries attached.

Thank you for your attention; I look forward to hearing from you.

Charles Medawar


16 October 2006 – Email reply from MHRA

Dear Mr Medawar,

Thank you for your email of 1 October about Sarah Wark's response to
your "para 11" queries on 4 September.  Your query has been passed to me
as the FOI Coordinator for the Vigilance and Risk Management of
Medicines Division.

The members of the CSM Expert working Group on SSRIs were supplied with
an assessment of MAH responses for the paroxetine referral at their
meeting of 27 Feb 2004. This assessment (of which I believe you have a
copy) contained a summary of the cases of suicide with paroxetine. I
would like to correct one of the points made in Miss Wark's letter of 4
September 2006. The case narratives themselves were not supplied to the
SSRI Expert Working Group but were supplied to the European scientific
advisory committee, the Committee for Medicinal Products for Human Use

Yours sincerely

Stephen Fawbert

Information for Public Health Group, VRMM
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-110
1, Nine Elms Lane
Tel: 020 7084 2788







13 June 2006 – By email

Dear Ms Wark, 

Thank you for your letter of 9 June, re FOI 06-181, your belated reply to my letter to you of 26 April.

You now tell me that the MHRA became aware in January 2004 that Patient 627.605.01012 was treated, shortly before his death by suicide, with clotiapine, oxazepam and fluoxetine. Yet on 13 February 2006, Dr Julie Williams wrote: "From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died."

You offered no explanation for this in your letter of 9 June, and I’m afraid I can only infer that the MHRA knowingly lied. However, I may have missed some nuance of this apparent deceipt. If so, I am sure you would want to put me right, as a matter of urgency.

If I don’t hear from you in the next day or two, I shall conclude the worst. I am that sick of the MHRA’s modus operandi that I’m copying this note also to Mr Goldfinch and to Professors Woods, Ashby and Gunnell.

Charles Medawar


13 June 2006 – By email

Dear Mr Medawar

Thank you for your e-mail. I can assure you that there was no attempt to deceive.

The case narrative is not specific about the timelines of treatment relative to the death. Our reading of the narrative is that the patient was treated with clotiapine, oxazepam and fluoxetine for an event which occurred one month before the death. There is no indication in the narrative that these medicines were continued to around the time of death; and similarly no indication that they were stopped prior to the death. Our response of 13 February could have highlighted this uncertainty and I apologise for any confusion caused.

Yours sincerely
Sarah Wark
Group Manager, Pharmacovigilance Risk Management
Vigilance Risk Management of Medicines
Medicines and Healthcare products Regulatory Agency
Tel: 02070842763


13 June 2006 – By email

Dear Ms Wark,

Thank you for replying so promptly to my mail but I am in no way reassured that "there was no attempt to deceive". If I wasn’t actually lied to, I might just as well have been: no matter that it was done by omission and leaves everyone feeling they are in the clear.

The Agency clearly bent over backwards to avoid the admission that that Patient 627.605.01012 was treated, shortly before his death by suicide, with antidepressant and other drugs. In my 17 February FOI request to Dr Julie Williams, I specifically asked: "does the MHRA stand by its affirmation that the patient was prescribed [a] no antidepressant drug (notwithstanding an impending ECT)? [b] no benzodiazepine? and [c] no antipsychotic medication? You failed to answer that question when its significance would or should have been perfectly clear to you, and now have the gall to offer some winsome apology. Moreover, the Agency’s reading of the case narrative appears thoroughly sloppy: because there was no indication otherwise, you simply take for granted that this patient was not taking those drugs shortly before his death – and, without further checking the facts, decide that this should be counted as a placebo suicide.

This whole episode leaves me feeling that the MHRA is absolutely not to be trusted and that something of a culture of mendacity seems to prevail. Please add this to the complaint this correspondence has already generated.

Charles Medawar