Mr S. Fawbert
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ	21 October 2006

 

Dear Mr Fawbert,

I am responding to your email of 16 October. At last, I get something closer to an honest answer to my FOI request (06/236) of 11 July, about the Seroxat "placebo suicides" – but only because I challenged yet another assertion from the MHRA that proved in the end to be the exact opposite of the truth. Ms Wark’s letter of 4 September refers.

So, Professors Ashby and Gunnell, and other members of the Expert Working Group on SSRIs never did get to see that ropey evidence – in spite of Ms Wark’s categorical assurance that they did. Only when I press the point, and formally request the MHRA to identify the date on which the evidence was allegedly provided, does the Agency finally admit that it never happened. This was a monumental admission, nothing like the tiny glitch your email so studiedly conveys:

"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 (CHMP)."

This was a huge admission for several reasons. It underlines the incompetence of the MHRA in coming to terms with the risks of SSRI antidepressants, and again it reveals the risks of paroxetine to be greater than the Agency was ever able to discover and/or admit, even after undertaking many enquiries over 15 years. This admission also suggests that the Agency compromised its relationship with the Expert Working Group, leading its members to the wrong conclusion.

Moreover, this is yet another example – one of a series in the past nine months – of concealment of truth in such a way as to rubbish my rights under FOIA. I still find it hard to disentangle the relative contributions of sloppiness and slipperiness, but the effect has been much same. For an Agency charged with "Safeguarding Public Health", and dependent on public trust, the MHRA’s posture seems really scary.

I could not work out from the tone of your email whether you either horribly did or horribly did not appreciate the significance of the issue. The admission you make had last straw written all over it, yet your email seemed almost dangerously bland. I’m still puzzling over it. I suspect that it was quite carefully deliberated and crafted, yet it may just reflect how disintegrated the Agency is, and simply be text of the kind that is routinely extruded from the MHRA in the due course of due process. To help me understand the relative contributions of incompetence and/or mendacity and/or whatever else, I would be grateful if you could address the following points:

1. 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.

2. 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.

3. 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?

4. 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?

5. 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.").

6. 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/until you are able to provide some better explanation).

7. 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.

8. 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.

9. 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?

I hope this makes clear also my deep dissatisfaction with your handling of this part of my FOI request. I assume that you communicated by email – failing to make any reference to my rights of appeal to the Information Commissioner – in line with the Agency’s "there is nothing to apologise for" posture. The further implication - that I could not possibly want to complain – seems all too reminiscent of the Health Select Committee’s finding of "serious weaknesses" in the MHRA and, specifically, its concern that, "the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings…"  

Where appropriate, perhaps the Agency should address these questions, not only by running them through the FOI sausage machine, but also by trying to come clean. In the meantime, all the evidence suggests that the main reason for the Agency’s consistent and improper obstructiveness in handling this FOI request, is to do with escaping embarrassment, and not having to admit to ghastly mistakes made over many years.

I would welcome any honest attempt to relieve me of feeling like a battered citizen, and the victim of something deeply analogous to scientific fraud.

Sincerely,
Charles Medawar

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