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Regulatory Agency

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

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E-mail [email protected]


                                                                                                                                           4 September 2006

Dear Mr Medawar,    


Further to Mrs Thyer’s letter of 4 August, please find below responses to your additional questions.

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.

The month’s delay in sending on Mr Fletcher’s report was an oversight on my part.

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.

Your e-mail of 14 June asked for your allegation that the MHRA had behaved deceitfully to be in included in your complaint. Relevant e-mails are attached.

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?

As far as I am aware the Agency at no time considered 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.

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.

The text of the narratives of the cases in question were supplied as annexes to assessment reports provided to the members of the Expert Working Group on SSRIs. I would ask that you direct any questions about the BMJ review (19 February 2005) to the authors.

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)?

As stated above the EWG were supplied with the case narratives.

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.

The MHRA did not undertake a critical review of the suicide cases or ask the MAH for further information on these cases. The considerations of the MHRA and Expert Working Group on the paroxetine clinical trial data have been supplied to you previously.

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"

If we had a particular interest in a case we would normally ask the MAH for the case narrative rather than asking for confirmation of specific details around the case, which can be open to interpretation.

Yours sincerely

Sarah Wark

Direct line 0207 084 2763