Ms S Wark, Post-Licensing Division
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ	10 July 2006

 

Dear Ms Wark,

This is to acknowledge receipt of your letter of 3 July and a copy of the review of my complaint by Mr Sean Fletcher, to whom I am sending a copy of this letter.

Mr Fletcher’s review neatly rounds off our correspondence about the Seroxat ‘placebo suicides’ over the past six months, and what has emerged is a classic case-history from which I expect to be extrapolating for years. I am preparing, in the first instance, representations about the issues arising to the Information Commissioner and to the Parliamentary Commissioner for Administration (PCA). The way in which the MHRA responded to my requests for information underlines the urgency of the conclusions and recommendations made in the recent report from the Parliamentary Health Committee:

"During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA… " (Para 376)

In the meantime, I have sent further requests for information relating to this case to Mr Goldfinch but enclose copies for your convenience.

Yours sincerely,                                                                 cc Mr Sean Fletcher
Charles Medawar

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