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Professor Sir Alasdair Breckenridge CBE
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

7 October 2004


Dear Sir Alasdair,

I received yesterday a letter dated 30 September from Dr June Raine. It does not refer to my freedom of information request to you, dated 29 September, nor apparently was it copied to you. The signal lack of reference to you, or endorsement by you, has its own significance. However, I’m sure you know what this letter says, and will appreciate why it’s so long and convoluted.

I am writing to you now to make it clear that I do not regard Dr Raine’s letter as a proper or adequate response to the Code of Practice request I sent you on 29 September. I specifically asked for copies of original documentation and, in particular, copies of documents prepared before 5 May 2004, when that statement was posted on the MHRA website.

Dr Raine’s letter made no attempt to explain why the MHRA considers it is not in the public interest that original (if redacted) documents be produced. I contend that the original documentation is needed, if critical questions are to be addressed. For example:

1. Was the outright dismissal of our criticisms of miscoding and lack of follow-up based on timely and considered judgment? Why did it take the MHRA over nine months to communicate its reasons for dismissing our concerns, and only after a formal request was made under the Code?

2. What analysis of our paper was undertaken when, and at what level within the MHRA? In what way, if any, was the leadership of the MHRA involved and informed, and what role did it play in endorsing the Agency’s assessment of our work?

3. Is the following example representative of the standard of investigation and reporting that the MHRA leadership relies on: "In some cases this automatic calculation (of reaction onset time) may not be appropriate and during transposition this field should be manually removed. This has not occurred in all cases"? How many cases, for heavens sake?

4. To what extent is the MHRA capable of recognising and learning from its shortcomings and limitations? Where is the evidence that the Agency can be trusted to do so – and why should it have considered any remedial action, when convinced that our criticisms were unfounded?

5. What can and does the MHRA do by way of defining priorities and finding remedies for problems – e.g. overcoming the "pressure on time" that Dr Raine says has limited the Agency’s ability to request follow-up information, even in the course of intensive reviews?

6. Were any of the ten very brief reports of suicidal behaviour (Table at 3.3. in our paper) followed up either routinely, or in the course of the reviews of the risk of suicidality? Which of the other apparently significant reports cited in our paper were or were not followed up, and why?

7. What judgment was involved, and on what basis, that there should be no follow-up of 58% of the reports of suspected suicidal behaviour – even in the course of two specific reviews? If there was no follow-up of over half of the reported cases, why should the Agency then have advised the public that our criticism of lack of follow-up was unfounded?

8. Does the MHRA also reject the main finding from our analysis – that the risk of suicidality might be related not only to the period immediately after starting paroxetine, but also following abrupt drug withdrawal and/or an abrupt dose increase?

Thank you for your fax confirming that you will respond to our Code of Practice request within 20 working days, from 29 September. I look forward to receiving the requested information.

Yours sincerely,
Charles Medawar