Mr Richard Goldfinch, Information Department
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ	10 July 2006

 

Dear Mr Goldfinch,

The following requests for information arise from the handling of my recent requests for information about the Seroxat ‘placebo suicides’ and the subsequent complaint reviewed by Mr Sean Fletcher (Your Ref: FOI 06-083 and/or -038). I am way beyond ‘deeply dissatisfied’ with the MHRA’s response to this information request. If the Freedom of Information Act permits such extremes of evasiveness, it calls into question the worth of the law itself.

The attached letter to Ms Wark and Mr Fletcher explains that I intend to pursue this case, hence these further information requests:

1. What is Mr Fletcher’s present job title and what titles has he held in the past five years? What is the status of Mr Fletcher, within the MHRA? In relation to [a] salary received, [b] length of service, [c] qualifications, [d] age, [e] title and [f] position, would it be fair to describe him as ‘senior’, junior’ or ‘equal’ to [a] Ms Wark and [b] Dr Williams?

2. On what basis was Mr Fletcher appointed as the complaint handler on this occasion: [a] How many previous complaints had he handled which involved passing judgment on the actions and/or conduct of his colleagues? [b] What scientific or other qualifications does he hold that would be relevant to his understanding the issues involved with antidepressants in general and the Seroxat ‘placebo suicides’ in particular?

3. Through what process was Mr Fletcher appointed? Please supply copies of all relevant standing instructions relating to the handling of complaints about MHRA staff by other members of Agency staff. If it is not clear from these, please state:

[a] whether Agency policies allow relatively junior staff to handle complaints involving more senior staff; and

[b] what number and proportion of complaints handled through internal review have involved such adjudication, over the past three years.

4. Please indicate whether Ms Wark and/or Dr Williams and/or any other person in the "Vigilance Risk Management" department of the MHRA –

[a] were consulted about the appointment of the complaint handler on this occasion;

[b] had access, in whole or part, to any draft conclusions in the report prepared by Mr Fletcher

[c] were invited to and/or offered comments on any part of any draft report.

And:

[d] Please provide a list of all MHRA staff interviewed, consulted and/or contacted by Fletcher in preparing his Review of this case.

5. Please supply copies of all email and any other record of communications and/or meetings between Mr Fletcher, Dr Williams, Dr Raine and Ms Wark (including all permutations thereof) relating to this case (FOI 06-083 or 038), and/or to me personally, dating between 25 April and 10 July 2006.

6. 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. On what date(s) did [a] Ms Wark [b] Dr Williams; and [c] Dr Raine first receive a copy of Mr. Fletcher’s completed review?

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.

8. Please identify and/or provide all "other relevant correspondence and enclosures", referred to at 4.1 of Mr Fletcher’s report, that were considered in his Review of FOI request 06/038.

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?

10. Re: Mr Fletcher’s conclusion (10), that "The Agency’s decision not to release patient numbers on the ground of the Section 40 exemption" (personal information) is justified: [a] was Mr Fletcher aware that the patient identification numbers of the three people recorded as ‘placebo suicides’ had been published (along with narrative details) on the GlaxoSmithKline web site one month before completion of his review? [b] was he aware that these three cases all involved US patients whose deaths had occurred five years previously or more; [c] was he aware that my request for these numbers was made simply to verify that the Agency and I were talking about the same cases? [d] On what basis did he presume that reference to a number, consisting of between six and eleven digits, might lead to the identification of any individual and/or cause anyone any distress; and [e] on what basis did he reject my argument that, "the whole numbering system universally employed to protect patient identity would fall apart", if Ms Wark was correct in assuming that disclosure of these long numbers "could potentially lead to the identification of patients"?

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 SSRIs? 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.

12. Had Professors Gunnell and Ashby and/or any other members of the CSM Expert Working Group (EWG) on SSRIs 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)?

13. Did the MHRA and/or any member of the EWG undertake any critical review of the suicide cases described in the above-mentioned 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. In my original FOI request, dated 16 January 2006, I 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"

[b] Please confirm (or not) that Mr Fletcher considered that Dr Williams gave a sufficiently honest response to my request, and that I had no grounds for complaint?

[c] Please state whether Mr Fletcher understood the reason for my query, "that it would be very unusual to subject a patient to ECT before some drug treatment had been tried". On what grounds did he decide not to treat as a complaint my critical view of Ms Wark’s response to this question?

[d] Mr Fletcher’s review states that he read all correspondence between the MHRA and me. Was he satisfied that I had no grounds for complaint, when Ms Wark (7 April) offered no response to my request: "Does the MHRA stand by its affirmation that the patient was prescribed [a] no antidepressant drug (not withstanding an impending ECT)? [b] no benzodiazepine? and [c] no antipsychotic medication?

15. Please confirm (or not) that Mr Fletcher decided I had no grounds for complaint about Dr Williams’ response to my asking (16 January) whether the MHRA was "entirely satisfied that the sponsoring company (MAH) fully and properly investigated the circumstances of each of the three placebo suicides" and, if not, "to identify in each case, what data were missing and why". Dr Williams replied that, "The level of detail in these cases is similar to that which would be expected in clinical trial adverse events". Did Mr Fletcher consider this was a truthful and appropriate answer, given that the narrative of the third placebo suicide case was as empty as described at 12[c] above?

16. Under Agency rules and procedures, would it have been considered [a] acceptable and/or [b] appropriate for Mr Fletcher to have made contact with me to ascertain what my complaint involved? Did he at any stage consider or propose this course of action and, if so, why did he not seek clarification from me?

I look forward to receiving the Agency’s response. My referral to the Information Commissioner and elsewhere will of course depend on the MHRA’s response, so I hope there will be no undue delay.

Sincerely,

Yours sincerely,
Charles Medawar

CLICK HERE TO READ ON