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Dr June Raine, Director
Post-Licensing Division
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

21 January 2003

        Dear Dr Raine,

I am responding to matters arising from your letter of 7 January (Ref OG 02/47) and your undated letter (Ref 02/49) received 18th January.

1. I would be grateful if you could send me the ADROIT Dictionary definition of "Electric Shock Sensation". In the ADROIT printout for paroxetine (December 2002), I can find no reference to this as a symptom relating to withdrawal from paroxetine. The only reference to electric shock I was able to find were seven cases listed under "Injury and Poisonings," implying exposure to mains electricity. Please tell me if I’ve misunderstood or missed something; in the meantime, I suspect that either the definition or the coding system may be seriously deficient. I welcomed your saying that the Patient Information Leaflet should be changed.

2. Of the total 40 reports of "electric shock sensations" on the whole ADROIT database, how many related to withdrawal from paroxetine and other antidepressants? I would be grateful too for a list of the other drugs implicated (with report frequency data), because that might give some clue to the medical significance of this phenomenon.

3. I am very concerned at your justification for making the statement, "there have been isolated reports of more serious symptoms on withdrawal such as severe electric shock sensations" and request that this be independently reviewed. The MCA’s explanation – " ‘isolated’ is a descriptive term and is not associated with a particularly frequency" – suggests the Agency to be barely capable of communicating with the public, misleading them as a matter of course. My complaint is this:

[a] This statement about "isolated reports" was part of an "important safety message" specifically targeted at people who might watch the Panorama programme, especially people taking paroxetine. For the MCA to say this doesn’t denote "any particular frequency" is evasive. A lay reader could only have inferred from this statement that the actual numbers were very relatively very low.

[b] The numbers were relatively very low mainly because of defects in the Yellow Card reporting and/or coding system – not because the number of cases is low. This would be clear to the MCA if it took due account of patient reports. The MCA may consider it is proper and scientific to extrapolate on this basis. I think it misleading and unfair.

4. You enclosed the SOP for classifying withdrawal reactions on the ADROIT database – but said it is not to be disclosed. What harm would be done by disclosure? Why is it in the public interest to keep it hidden? Under what exemption of the Code of Practice is the MCA seeking to restrict disclosure?

5. In your letter received on 18 January (point 7), you say, "we do not at present have data that would allow us to accurately calculate the extent of under-reporting of withdrawal reactions." My strong impression, based on contact over the past five years is that, if the MCA/CSM don’t have data, it’s mainly because they haven’t looked for them. The Agency seems to be hiding behind the word "accurate" – as if anything less than perfect is meaningless. Others have produced best estimates on the basis of existing data, and also make efforts to keep improving them. Have the MCA/CSM not done so? The reference to, "at present" seems a bald invitation to the reader to assume that something is on-going and that evidence is on its way. Is it?

6. In the same letter (point 8), you exempt the MCA from responsibility for investigating how doctors often mistake withdrawal symptoms with relapse, on the grounds that "these are matters relating to clinical management." Breathtaking – and all the more reason for listening to patients and reading what they have to say. (Apropos of this, please get in touch if you would like to discuss your plans to "roll out" patient reporting next month, via NHS Direct. I’d be happy to discuss what this initiative might not be expected to achieve.)

7. Re point 12, I didn’t ask to you to comment on the feelings of individual patients. I asked if the MCA/CSM accepted that many patients are caused much distress when poorly-informed prescribers confuse withdrawal symptoms with relapse. Never mind.

8. Your response on point 18 was also evasive. If you were going to duck the question I asked on those grounds, why did it take seven months to do so?

9. Re point 22. Now that the MCA/CSM is aware of the report discussed at the 33rd meeting of the WHO Expert Committee on Drug Dependence, and is also aware that I attended that meeting by invitation, it is seriously going to defend the decision to have debarred me from the meeting on 21 November on the grounds that, "he is not a scientist"?

10. Your equivocations are noted in comments on each of the three points on which I asked for comment (point 24). They were in fact verbatim statements from the above-mentioned WHO report.

11. Your letter also ducks point 25. Professor Mackay’s name remains attached to a still widely quoted paper, which reaches and propagates erroneous and misleading conclusions about SSRI withdrawal problems on the basis of poor interpretation of inadequate data. I asked if this was acceptable to the MCA; your reply clearly suggests it is. I fully accept what you say about Professor Mackay’s knowledge, skills and experience in clinical research, academic research and medicines regulation, but that’s not the point. Making mistakes is not the problem; failing to correct them is. Until Professor Mackay feels able to acknowledge that his and his MCA colleagues’ earlier assessment of withdrawal problems was inadequate, confidence in his chairmanship of an important MCA/CSM review committee is likely to be impaired. Nor do I understand how the MCA/CSM can remain so indifferent when, as you acknowledged in point 11, "we would fully accept that spontaneous reporting cannot be used to calculate the incidence of adverse reactions." That is exactly what Professor Mackay and his MCA colleagues attempted to do and the published paper makes it clear they did so in the name of the MCA/CSM.

Yours sincerely,
Charles Medawar


Contents page
List of correspondence with MCA/CSM