|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)171 586 7771|
|Dr Keith Jones, Chief Executive|
|Medicines Control Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||14 April 1998|
Thank you for your April 1st letter. I'm afraid it took a week to reach me, too late for any joke.
Your response on the question of disclosure about paroxetine withdrawal reactions in clinical trials was rather what I expected. It wasn't so much that I thought the MCA would disclose, but I did want to learn how this would be explained.
Your letter didn't even address the key question, yet it does answer it. The more you argue that secrecy is needed on this occasion, the more it seems that disclosure would discredit the drug and the manufacturers, and probably the MCA as well. Thus the more harm you think would be done to the Company, the more I think that patients are at risk of being harmed - and the more I try to get to the bottom of this, the more I think in terms of 'regulatory capture'.
This will continue at least until I get a straight answer to the question: What harm? (ie the MCA shouldn't expect me to believe that disclosure would really harm the competitive position of the company, more than risk the health of patients, so long as it can't/won't begin to specify how - and apparently sees no need to do so).
Past experience suggests that a formal complaint to Room 2015 would not be worthwhile. It look three months last time before learning that the core issues were far beyond your Assessor's remit. This is not one for the long grass, nor for the British Journal of Clinical Pharmacology - same difference here, except that the journal would also be defending its reputation in the light of sure evidence that their peer-review process is deficient).
Your decision about the MCA/CSM paper was more unexpected, but no less revealing. Again, you cling to procedure and steer clear of the central point, but I shall not be backing off: that paper ought to be an embarrassment because it shows that MCA/CSM research methodologies and interpretations are way out of line, as are the absurd understatements/underestimates given of withdrawal and dependence problems.
In eight months of correspondence, the MCA has never once expressed concern about any of this, nor given any indication of thinking it might have been mistaken in any part of the analysis. Accordingly, there has never been any suggestion that the MCA might lift a finger to improve anything. This lack of responsiveness is startling.
I enclose with this letter a table including notes about all the published reports I have been able to find of withdrawal and dependence-related related problems with SSRI antidepressants. This is designed to be read in the light of two considerations that the proverbial man or woman on the Clapham Omnibus could hardly miss:
1. Who is going to read this lot, plus all the Yellow Card evidence, and agree with the MCA/CSM that withdrawal problems are rare and mild, and that there is no risk of a major dependence problem?
2. In the light of these risks, is it not mind-boggling to see 1998/99 Data Sheets that contain no warnings (eg fluoxetine) or bland footnote-style reassurances about apparently insignificant events? (eg "Symptoms, including headache, nausea, dizziness and anxiety, have rarely been reported after abrupt discontinuation of Faverin", or "Rare cases of withdrawal reactions have been reported" with sertraline.)
I appreciate the MCA/CSM will not feel comfortable to be accused of incompetence and abuse of public trust, but I would at least ask you to accept this is partly because their public relations are a disaster.
I also see your letter as a dismal portent of the new openness we have been promised. Here is the MCA, on the brink of new law, deeply dependent on its client companies, financially and otherwise and, after years of exposure, addicted to secrecy which serves its clients' and its own interests, not to mention some professional reputations. How on earth is the MCA going to make the transition to openness when, even now, some tiny act of disclosure seems to threaten client companies, and therefore the future supply of confidential information on which the agency has always relied?
It seems to me either that the new law won't make any difference to medicines' control, or that the MCA/CSM need a complete overhaul. My experience over the past few months has convinced me that the MCA will need to find a truly different spirit and attitude if freedom of information is to mean anything much to medicines' users.
You declined to comment on Professor Rawlins' remarks about the complete lack of justification for all the secrecy solely on the grounds that he was expressing a personal view. It was open to you to give just the slightest hint that at least the odd subversive within your ranks might be inclined to think Prof. Rawlins has a point. But no.
In these circumstances, you really should not "trust" that I "will understand and accept this position". On the contrary, the more the MCA denies everything - deferring to hosts of unnamed and unaccountable experts who share its views - the less inclined I am to accept the position, and the more determined I am to challenge it. I have yet to receive the MCA response to my Code request dated 11 February, asking just for the names of experts the MCA is supposed to have consulted. I can wait, but this and all the other delays fall well short of the "speedy and effective" responses the MCA claims it gives.
I would appreciate a reply; I am therefore sending a copy of this letter with attachments to the offices of the Prime Minister, Chancellor of the Duchy of Lancaster, Chief Medical Officer and Secretary of State for Health.
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