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Mr Roy Alder, Head of Executive Support
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

2 October 1998

Dear Mr Alder,

Thank you for your 11 September reply to my letter of 3 August arising from our Complaint to the Ombudsman (PCA). I regret this hits a new low for us, by far.

1. You wrote that you were "now in a position to respond" to questions which date back to last March, blandly superceding your emphatic refusal a few weeks earlier to undertake to reply by any particular date. It was this that pushed us to the brink, and our complaint was made only after we had gone to inordinate lengths to get some sense out of the UK medicines control system. We had more than exhausted domestic remedies in half a megabyte plus of correspondence, lasting over a year - and were still no closer to the facts and truth.

All this time, we have been positively hurdling through your administrative hoops, making the most strenuous efforts to join in the guessing games and satisfy the quaint requirements of bureaucracy. We have endured long delays and silences, carefully crafted obfuscations and wily use of words - and, even now, we are up against the CSM's crushing use of law. Yes we felt we needed the Ombudsman's help and, in the light of what your letter says, it seems we need it all the more.

I assume it was our complaint to the Ombudsman that finally concentrated the MCA/CSM mind. I also interpret the very existence of your letter as an attempt to persuade an already overburdened PCA that he need not take up the complaint after all. This perhaps explains your saying our complaint might be referred to the Ombudsman. Our complaints were in fact referred by Richard Shepherd MP, weeks before you replied - and I certainly hope the PCA will decide to investigate further, if only to look into the strong possibility that the MCA/CSM has been wasting everybody's time on a grand scale. More important, however, are many questions about where secrecy should begin and end, and how safe medicines should be.

In the remainder of this letter I draw attention to such matters that the PCA might wish to consider, in the light of your sweeping refusals to disclose and the weakness of the justifications offered for it. I will come to your specific points, but there continues to be profound disagreement between us in these general respects:

[a] We have very different understandings about declarations of possible conflicts of interest, and I believe yours conflicts with stated public policy. Your claimed exemptions (see 6 below) are contradicted by Clause 3 of the Code of Practice on Declaration of Interests: "Ministers have decided that the arrangements which govern relationships between members and the pharmaceutical industry on significant and relevant interests should be on public record."

[b] I think the MCA/CSM fails to distinguish between the individual and collective rights of CSM members. Your interpretations have invariably accorded to the whole (corporate) CSM, rights that were intended to protect the individual member. Accordingly, and in spite of several requests, you have refused to provide any document from which sensitive and exempt information could have been deleted. It seems most unlikely there should be no fragment of any documents requested that might properly be disclosed.

[c] The MCA/CSM claim to be able to make proper and realistic assessments of "the public interest" in relation to disclosure of information concerning their own performance. I think this inconceivable for any organisation so secretive, remote, and unusually representative of vested interests, especially in this day and age. Even MI5 has a website now.

Turning to specific points, I follow the numbering in your letter:

2. I still think it improper that Professor Rawlins and the CSM should have referred my questions to the MCA. This correspondence began with questions about some of the sweeping claims Rawlins made at the King's Fund Centre debate on 3 March and in his 8 May letter to me. Having sounded off, it has to be up to him to explain and justify what he said, instead of legally slipping off to a secret bunker.

3. The criteria you say were used for deciding each of our requests omit any reference to the public interest in disclosure. I believe you.

4. I raised questions about CSM members' declarations of interest, being concerned that over half of all members have personal interests in at least one pharmaceutical company - of whom about one-third have interests in a company marketing an SSRI.

I still think this a proper concern; indeed I recently discussed the situation with a member of the Committee on Standards in Public Life who appeared quite perturbed that any member should have such interests to disclose. I found myself in the curious position of defending the CSM - which I now rather regret, given your refusal to disclose whether, when and how such conflicts of interests had ever arisen.

5. On the face of it, it seems quite extraordinary that only two CSM members declared personal interests relating to only one SSRI during the 11 year period in which six such drugs were licensed. However, the exclusions and caveats in the data provided make it impossible to determine exactly what has been going on - which is, I imagine, exactly what the MCA/CSM had in mind.

6. You have refused to disclose details of CSM members' declared conflicts of interest in effect on the grounds that they are entitled to privacy and/or that the information requested was either "part of the deliberative process" or "confidential", or whose disclosure would "risk damaging the working relationships" on which you all depend. Under clause 3 of the Code on Declaration of Interests this refusal seems quite unjustified; see 1c above.

7. You say that all information relating to the CSM's discussions about secrecy is itself secret. If this does indeed satisfy the Agency's obligations under the Code, it would seem to bring the Code itself into disrepute.

8. You are saying that every last detail of any CSM minute must be kept secret in the public interest - even name, rank and number attending? Aaarrgghh.

9. The CSM may not be bound by the Code, but this does not excuse conduct unbecoming. See my letter of 27 September.

10. Ditto the refusal to disclose any indication of the thinking behind the CSM's blanket refusal to respond to any of my enquiries.

11. For reasons explained in my 30 September letter to Dr Wood (copied to you) I believe [a] that the review you say the MCA/CSM is continuing was effectively completed three months ago; and [b] MCA/CSM risk assessment procedure is seriously defective.

12. The decision to treat the questions I asked Professor Rawlins on 10 June as Code requests seemed to me inappropriate in the extreme: see my letter of 27 September. The answers provided are evasive and uninformative to an extent the scientific community might find rather shocking.

I am sending a copy of this letter to Richard Shepherd MP in the hope he may decide to draw it to the PCA's attention.

Yours sincerely,
Charles Medawar


Contents page
List of correspondence with MCA/CSM