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Regulatory Agency

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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]
www.mhra.gov.uk

  

 Sent by e-mail and hard copy                                                                                                        4 August 2006

Dear Mr Medawar,    

Thank you for your letter of 10 July to Richard Goldfinch following the internal review of your complaint - MHRA reference FOI06/038 (I confirm that this is the correct reference and not FOI06/083).

Requests for information made under the Freedom of Information (FOI) Act are dealt with by those within the Agency who deal with that subject as part of their day to day responsibilities. To provide an independent focus, internal reviews are handled within the Policy Division by two officers specifically designated to do so in addition to their usual duties and who have no policy responsibility for the implementation of the FOI Act. These two officers are Mrs Sue Jones, who is the Agency’s Complaints Officer, and Mr Sean Fletcher, who works for Mrs Jones.

As you know, internal reviews provide an impartial means of reviewing decisions made during the original consideration of whether to release information. The purpose of the review, as set out in guidance issued by the Department of Constitutional Affairs, is to consider whether the correct processes were followed and if any decision to invoke an exemption was appropriate. To that extent, it is not, in my view, a requirement that the person handling the review should possess a detailed knowledge of the subject of the FOI request. Indeed, it would be difficult to identify someone with such a knowledge that had not already been involved in handling the original request.

Nor is it the purpose of internal reviews to respond to new requests for information. I understand that Mr Fletcher made clear in his reply to you of 3 July that his review did not address the new requests contained in your letter of 26 April. I further understand that Miss Wark has now replied to those requests. Your latest letter of 10 July to Mr Goldfinch also contains new requests for information and I append a note of those new requests which have now been forwarded to Miss Wark for her attention (under reference FOI06/236). I apologise that due to my oversight those requests have only been forwarded today to Miss Wark.

I turn now to the questions you have raised about the internal review and use your numbering for convenience.

Para 1: Mr Fletcher joined the Agency in 2001 as the Litigation and Legal Services Manager in the then Executive Support Division (now Policy Division) and that remains his title. While Mr Fletcher is legally qualified, he holds an administrative post within Policy Division and undertakes a range of administrative duties. Under the Department of Health/MHRA system he is graded as an IP3 Standard 2 which carries a salary range of between 24,965 and 37,037. I do not consider that Mr Fletcher’s actual salary or his age has any bearing on the execution of his official duties and I decline to provide that information under section 40 of the FOI Act. In my view, release of this personal information relating to Mr Fletcher to a member of the public would breach, in particular, the first data protection principle (requiring that data must be fairly and lawfully processed). The replies to a number of your sub-paragraphs are covered above but for ease they are repeated here: 1[a] - salary: see above, 1[a -sic] - 5 years, 1[c] qualified as a lawyer 1[d] - age: see above [f] - position: see above. Also, there is no direct "read-across" of grades within the Agency. Miss Wark and Dr Williams are among the professional staff of the Agency and Mr Fletcher is one of the administrators within the Agency’s Policy Division. Generally speaking, the professional staff of the Agency are within the Senior Civil Service organisation so to that extent Mr Fletcher would be "junior" in comparison.

Para 2: As outlined above, internal reviews are handled by either Mrs Jones or Mr Fletcher and allocation of individual cases depends on their availability. 2[a] - Mr Fletcher first undertook these duties in March this year and to date has completed 6 internal reviews. All have required him to judge how others within the Agency have dealt with FOI requests, 2[b] none - the purpose of a review is to consider how others in the Agency have dealt with FOI requests and this does not, of itself, require an expert knowledge of the subject matter.

Para 3: Mr Fletcher’s appointment to undertake internal reviews followed the usual, albeit undocumented, arrangement of expanding his role to provide an additional resource for this work and to assist Mrs Jones. No instructions exist which specifically relate to the handling of complaints about MHRA staff by other members of Agency staff. However, the answers and my comments to your two questions are as follows: [a] I refer above to your reference to "junior" and "senior" staff. Mr Fletcher is not a junior member of staff within the Policy Division (nor is Mrs Jones) and it is perfectly appropriate that they should undertake internal reviews of FOI decisions made by Agency staff whether in the professional or administrative grades, [b] a total of 28 internal reviews have been completed since January 2005. I have not looked at each one in detail but at least 18 will have been completed by Mrs Jones/Mr Fletcher and relate to decisions originally taken by staff in the professional group.

Para 4: [a] - no, [b] Mr Fletcher provided a draft of his report to Miss Wark to check for factual accuracy only, [c] - same answer as [b], [d] - no staff were interviewed.

Para 5: the only communication was that referred to at 4[b] plus a note to Miss Wark following completion of the report - see attached e-mails. (I do not understand your request for copies of documents between yourself and the Agency, as you will already have these.)

Para 6: a copy was sent to Miss Wark on 8 June.

Para 8: the terms of reference identified at 4.1 of Mr Fletcher's report, are standard for all internal reviews. Sometimes there is additional correspondence, sometimes not. For your review, Mr Fletcher had sight of your e-mail/letter of 16 January, Dr Williams’ reply of 13 February, your letter of 17 February, Dr Williams’ acknowledgment/contact/reply of 17 March, 4 and 7 April and, of course, your letter of 26 April.

Para 10 ; [a] I understand that Mr Fletcher was not aware that the patient identification numbers of the three 'placebo suicides' had been published, [b] no, [c] no - under the FOI Act, the reasons why requests are made have no relevance except in very specific circumstances described in guidance issued by the Department of Constitutional Affairs. [d] and [e] it is long-standing practice in the Agency to protect patient confidentiality and, by association, the confidentiality of any family members that might be caused distress by the public disclosure of sensitive information concerning, for example, death by suicide. While a numbering system in itself is not confidential, each reference is linked to a case where, if the sample is small, can be linked through other external sources, such as death certificates or news articles to identify actual individuals. That was therefore the basis of Ms Wark’s comment that disclosure of these references could potentially lead to the identification of patients and Mr Fletcher’s review saw no grounds to dispute that view.

Para 14: [b] your reference to Miss Wark’s reply is presumably her e-mail to you of 13 June 2006 which was outside the review period undertaken by Mr Fletcher which looked at the handling of your requests prior to 26 April (which was the date you requested the review), [c] the Agency cannot comment on decisions about the care provided to individual patients. These are matters for the patient (or patient’s representative) to take up direct with the relevant healthcare body, [d] your request of 17 February was two-part and the confirmation you requested appeared to depend on the Agency obtaining further details from the MAH, which Miss Wark declined to do on 7 April.

Para 15: there was and remains no indication that Dr Williams’ reply of 13 February was given other than in good faith at that time. Your subsequent requests of 17 February and 26 April raised further questions in relation to that particular query and replies were sent on 7 April and 9 June.

Para 16: it would certainly have been acceptable for Mr Fletcher to contact you if he considered this would have been beneficial to the review. This was entirely a matter for his judgement.

You are already aware of your right of appeal to the Information Commissioner and I note your intention to do so.

Yours sincerely

Anne Thyer

Anne Thyer
[email protected]

CLICK HERE TO READ REPLY

EXTRACT FROM LETTER OF 10 JULY 2006: TO BE REGARDED AS NEW REQUESTS FOR INFORMATION UNDER THE FOI ACT UNDER REFERENCE FOI 06/236

Para 6 (part) Please explain why Mr Fletcher's report, dated 8 June 2006, was not sent to me before 3 July, i.e. why there was nearly a month's delay.

Para 7. Please provide all available documentary evidence relating to the action(s) taken by Ms Wark on receipt of my email to her of 13 June 2006, requesting that my complaint should include my allegation that the MHRA had behaved deceitfully, in responding to my request for information about drugs given to patient 627.605.01012, shortly before his suicide in March 1999.

Para 9. In her letter to me of 3 July 2006, Ms Wark wrote that she "would like to confirm that the Agency does not consider that a report of suicidal behaviour occurring more than 30 days after therapy was stopped should have been included in a post-treatment plus 30 day analysis". Ms Wark's use of the word, 'confirm' (suggesting she would want readers to believe she had previously attempted to communicate this) prompts me to ask whether the Agency ever considered it was appropriate to count this case as a 'placebo suicide'? If Ms Wark was in any sense 'confirming' the Agency's position, what is the explanation for the 3-month delay and protracted correspondence involved in establishing that the inclusion of this case was inappropriate?

Para 11. Were the "Narratives for Cases of Suicides in Clinical Trials" (supplied to the MHRA by GSK in January 2004, as Appendix 6, in response to the Seroxat Article 31 submission) made available to [a] Professor D Ashby; [b] Professor D. Gunnell and/or [c] to any other member of the CSM Expert Working Group (EWG) on the Safety of SSRls? If so, please explain why did the Gunnell/Ashby review in the BMJ (19 February 2005) state: " . . . we did not have access to individual patients' data . . ." and if they were not supplied, please explain why not.

Para 12. Had Professors Gunnell and Ashby and/or any other members of the CSM Expert Working Group (EWG) on SSRls been informed, by this or any other documents or information supplied to them by MHRA staff, by the time of the publication of the EWG report (December 2004), that the three so-called 'placebo suicides' in the paroxetine trials comprised: [a] one case improperly included because death occurred beyond the 30-day cut-off point; [b] one case in which the patient had been treated with fluoxetine, oxazepam and clotiapine shortly before committing suicide; and [c] a third case in which the supposition that the patient committed suicide was apparently made solely on the basis of two telephone calls from the brother of the deceased - the first reporting this patient had 'passed away', the second 'confirming' the patient committed suicide (by unrecorded means)?

Para 13. Did the MHRA and/or any member of the EWG undertake any critical review of the suicide cases described in the abovementioned Appendix 6? If so, please provide a copy of any assessment(s) made. If not, [a] please confirm (or not) that the MHRA and EWG were satisfied that none of the nine reported cases of suicide on paroxetine were possibly or probably attributable to ingestion of the study drug; [b] please state whether the MHRA requested any further information from the MAH about any of the cases described and, if so, what information was requested about which cases; and [c] if any such information was requested, please supply copies of all information provided by the MAH in response to that request.

14 (part) . In my original FOI request, dated 16 January 2006, 1 asked "Can the MHRA confirm that none of the three people on placebo who committed suicide during the post-treatment phase had been taking an antidepressant drug at or around the time they died?" In her reply, dated 13 February, Dr Williams stated: "it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died" - however, Ms Wark has now admitted that this patient had been administered fluoxetine and other drugs, also that the case narrative gave no indication that these drugs were stopped before the patient's death. In this connection:

[a] Please confirm (or not) that the Agency would have been satisfied if they had addressed the same question (as mine) to the MAH and been told: "it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died"

E-MAILS ATTACHED

From: Fletcher, Sean
Sent: 01 June 2006 11:37

To: Wark, Sarah
Cc: Jones, Sue; Bagwell, Martin; Wilson, Stephen

Subject: FOI Review - 06/038
Attachments: FOIReview06-038draftreport010606.doc

Sarah,

Please see attached my draft report for the above FOI review.

Could you please check the report and confirm that you are content with its factual accuracy. I'd be grateful for your response by Wednesday 7 June if possible.

Thanks

Sean 

From: Fletcher, Sean
Sent: 08 June 2006 14:42

To: Wark, Sarah
Cc: Jones, Sue; Bagwell, Martin; Wilson, Stephen

Subject: FOI Review 06/038
Attachments: FOIReview06-038finalreport080606.doc

Sarah,

I attach the final report for the above review.

Please note that I do not send a copy of the report to Mr Medawar. It is for VRMM to progress this matter further with him.

Regards

Sean                                                                                                  

           CLICK HERE TO READ MHRA RESPONSE

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