MHRA-LOGO.gif (6825 bytes) Medicines and Healthcare products
Regulatory Agency

Market Towers
1 Nine Elms Lane, London SW8 5NQ


Mr Charles Medawar
Social Audit Ltd
P.O. Box 111
London NW1 8XG

General enquiries
Telephone 020 7273 0000  Fax 020 7273 0353
E-mail [email protected]


                                                                                                                                           20 November 2006

Dear Mr Medawar,    

FOI 06/350  

Thank you for your further letter of 21 October 2006 about Seroxat in response to my email of 16 October, ref 06/324. You have raised a number of points and I will answer them in the order in which you raised them.

Please provide copies of all emails and any other record(s) of communication relating to me and/or this FOI request, sent from and received by your office during October 2006.

Please find information you requested attached. Names of MHRA staff have been removed under Section 40 of the Freedom of Information Act.

Please provide copies of all emails and any other record(s) of communication relating to me and/or this FOI request, exchanged between the Agency and Professor Ashby and/or Professor Gunnell, at any time.

No emails or any other record(s) are held by the MHRA of communication between the Agency and Professor Ashby and/or Professor Gunnell about you and/or this FOI request.

If it is not clear from (2) please state whether any apology was offered to Ashby or Gunnell for Ms Wark’s error in telling me they had received the narratives of the three placebo suicides, and then directing me to them. What apology was given and by whom – and what if any remedies were proposed?

As outlined above, there has been no communication between the Agency and Professor Ashby and/or Professor Gunnell about you and/or this FOI request

Was any consideration given to offering an apology to me? If not, would this be consistent with MHRA Standard Operating Procedures (and please supply the relevant documentation)? If so, why did your email convey so emphatically that there was nothing to apologise for?

No MHRA Standard Operating Procedure includes advice on offering apologies, but that would not deter any member of the Agency from offering an apology where appropriate. I am sorry that Ms Wark’s letter of 4 September contained an error, but at the time of writing we believed the information to be correct. I am sorry that this meant you had to write to me again about this matter and I apologise now for any inconvenience this error has caused.

Why have I not yet received a response to that part of my 11 July FOI request (11c) that asked the Agency to explain the reason(s), if case narratives of the three Seroxat placebo suicides had not been supplied to the EWG? ("… if they were not supplied, please explain why not.").

When drafting any assessment report a judgement is made as to what level of detail to supply with the assessment report. It must have been judged at that time that it was not necessary to supply the case narratives. There is always the facility for experts to request further detail should they consider it necessary having read the assessment report. I understand that further details were not requested.

Please now explain why the case narratives were supplied to the CPMP, but not to members of the Expert Working Group on SSRIs – when their focus was very specifically on this issue. (I would be reluctant to accept this was an "oversight", in spite of the many precedents. All the evidence suggests that someone took a conscious decision to withhold those data – and I shall continue to believe that unless you are able to provide some better explanation).

The review of the risks and benefits of paroxetine by the CPMP was conducted in the context of a formal referral procedure from the Agency to the CPMP. This procedure is entirely separate from the consideration by the EWG. As is normal practice in these procedures the complete response of the MAH to the list of questions of the CPMP was sent to all CPMP members.

You did not attempt to answer that part of my 11 July FOI request (para 12) that asked the Agency to state whether members of the EWG were ever advised that the evidence for the three alleged Seroxat placebo suicides was completely unconvincing. Ms Wark responded to this saying, "As stated above, the EWG were supplied with the case narratives", which we now know is not true. Please now address this point, explaining why such vital and relevant information was never discussed, if this was so.

I understand that you have copies of all of the papers relevant to paroxetine that were considered by the EWG and of the minutes of those discussions. The EWG was provided with two different analyses of the paroxetine clinical trial database. As you will see from Chapter 7 of the report of the EWG, their focus was on considering trends across the trials across all products rather than detailed analysis of individual cases within trials. In commenting on the limitations of the available data the EWG stated that ‘because suicide is rare even in patients with depressive illness, most clinical trials have too few cases to confirm or rule out an increased risk of suicide with antidepressants.’ The EWG also was very conscious of the lack of rigorous recording of cases of self harm in clinical trials.

What explanation can you give for the complete absence of any comment on, or evaluation of, the three alleged Seroxat placebo suicides by the Assessor (See Assessor’s detailed assessment of MAH’s response p. 47). Did the Agency consider this information insignificant or irrelevant? Was this an oversight, negligence or what? It seems incomprehensible.

As explained above, the focus of the EWG in the analysis of clinical trial data would have informed the focus of the assessor in drafting the report. Subsequently, the case narratives were submitted to the CPMP and the conclusion the CPMP reached was consistent with the advice of the EWG.

What if any formal or informal disciplinary action has been taken against Ms Wark or any other MHRA employee in connection with this particular lapse in handling my FOI request? Would anything be gained if I made a formal complaint or have ‘lessons been learned’ – and, if so, what might they be?

Any action surrounding the performance of official duties by an individual member of MHRA would be a matter for the individual’s line manager and the Agency’s Human Resources Department. If any action had been taken - which I can neither confirm nor deny - it would not be disclosed under Section 40 of the Freedom of Information Act (personal information). If you remain dissatisfied with the way the Agency has handled for requests for information, your recourse is to an internal review and subsequently to the Information Commissioner.

You also raised a couple of associated issues. I communicated to you by email on 16 October as this is my preferred method of communication, being quick with the added benefit of saving paper. As you had sent a copy of your letter to the MHRA electronically, I had assumed you would be happy to receive a reply electronically. I am sorry if this was not the case. A hard copy of this letter will therefore be sent by post.

I did not include information on your "right of appeal" to the Information Commissioner in my email of 16 October as I had not withheld any information under the FOI Act.

We have already shared with you all the papers and minutes of Expert Working Group meetings and the report makes it quite clear what evidence their findings were based on. I hope the information contained in this reply, which gives further information on why the EWG received the evidence it did, answers any remaining questions that you have on this matter.

Yours Sincerely

Stephen Fawbert
Freedom of Information Coordinator
VRMM Division



Email 2

From: [text redacted Section 40 FOIA]
Sent: 13 October 2006 17:20

To: [text redacted Section 40 FOIA]

Cc: [text redacted Section 40 FOIA]

Subject: FW: FOI 06/324 (re. 06/236)

[text redacted Section 40 FOIA]

I suggest the following response:

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 04. 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 (CHMP).