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Dr Keith Jones, Director and Chief Executive
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ 7 May 1998

Dear Keith,

NOT PRIMARILY ABOUT PAROXETINE (SEROXAT)

Many thanks for your letter of 1 May, which emphatically missed the point of my 14 April letter to you.

I thought I'd made it clear I would not appeal the Agency's refusal to provide data on paroxetine withdrawal, not even in the light of your continuing refusal to specify what harm might be done. The only thing you've said is that SKB told you that disclosure would be harmful and that you agreed. This still seems ridiculous, both because you won't give reasons and because almost exactly the data I asked for is on the public record across the pond.

The US paroxetine Label says that fewer than 1/1,000 cases of "drug dependence" and "withdrawal syndrome" were observed in pre-marketing trials. That means these ADRs were recognised in four or fewer patients each - which is the "harmful" information I asked you for. The precise number doesn't much matter: the point is that it is so low.

This adds to evidence, which goes back a long way, that the MCA/CSM is prepared to rely on trials which are poor if not misleading predictors of clinical reality. It also underlines the risk of a replay of the benzodiazepine fiasco, again with the regulators playing a puny but decisive part. The idea that risk can be reduced simply by redefining the meaning of "dependence" seems extraordinary. The brand new meaning of this word has more or less abolished the conceptual basis of public understanding of "dependence".

How could the MCA/CSM have accepted all this - without a murmur, nor word of explanation - when the change was achieved through a "consensus" of all vested interests bar consumers, and has promoted diagnostic criteria so remote from common meanings and sense?

Attached to this letter are some examples, from lecture slides, of what they used to call "dependence", before this sleight of meaning was achieved. Surely these will convince you: [a] that the existence of withdrawal syndrome signals dependence - all the more so when most GPs appear not to know that antidepressant withdrawal even exists; [b] that the benzodiazepine problem was overwhelmingly characterised by therapeutic (or iatrogenic) dependence, without features of abuse; [c] that on the definitions of dependence used until recently, the SSRIs would certainly have been classed as drugs of dependence; and [d] regardless of the relative merits of the new and old definitions, the public would inevitably now be very confused about what "dependence" is.

Perhaps all this comes closer to the harm the MCA imagined might be done by disclosure, and explains why you feel justified in keeping everything secret. Suffice it to say I am ever less impressed by your insistence that "the MCA is committed to making as much information publicly available as possible."

The distance between us is such that I would not know whether you even raised an eyebrow at the list I sent you of 60 published reports of SSRI withdrawal reactions. By not reacting to those questions per pro the folks on the Clapham Omnibus, you seem to be inviting me to believe that the MCA/CSM really are oblivious to the risks, and quite satisfied with pathetic warnings in data sheets. But I'm not convinced. I may be a silly old optimist but I still like to imagine that some of you down at Market Towers/Canary Wharf might be thinking about catching the bus, rather than just hoping the problem will go away.

I'll be pursuing these issues anyway, rather than waiting for history to happen. I'll admit to wondering, once in a while, if there are not better things to do with my head than solemnly banging it against a brick wall - though I appreciate it might feel to you more like a head butting. Either way, I feel sure there are several diagnoses for it in DSM IV.

Yours sincerely, 

Charles Medawar
   

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