Social Audit Ltd
P O Box 111 London NW1 8XG
Telephone/Fax 44 (0)171 586 7771
Dr Susan Wood
Post-Licensing Division
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ 24 December 1997

Dear Dr. Wood,

Thank you for your undated letter, received on 19th December. Before I decide whether or not to appeal the Agency's refusal to release the data about paroxetine I requested in my letter to Dr Price on 23rd October, perhaps I can query a few points with you. I would be grateful for your comments on the following:

1. I repeat my request that you withdraw the paper that prompted my enquiries in the first place (Price JS, Waller PC, Wood SM, Mackay VP, Br J Clin Pharmacol 1996, 42, 757-763). You may not feel able to disclose the extent of withdrawal reactions seen in the trials, but would have more than enough information to be able to conclude now that it is quite wrong and potentially damaging to suggest that the risk of SSRI withdrawal reactions may be so low as to be "undetectable except through spontaneous reporting where drug exposure is high."

2. You refused my application partly on the grounds that "disclosure may harm the competitive position of a third party" (ie the license holder, SmithKline Beecham), but I do not think that this is what exemption 13 of the Code either says or means. Exemption 13 refers to "information including commercial confidences, trade secrets or intellectual property whose unwarranted disclosure would harm the competitive position of a third party".

[a] the test here is that disclosure "would" harm, and not "may" harm, as you say. Would it cause harm and, if so, how? And why would it cause harm if, as Dr Price has claimed, the incidence of withdrawal reactions in the paroxetine trials "was less than that seen with commonly used antidepressants"? Surely, the license holder would have been delighted if this were in fact the case, notwithstanding the obvious inference that the trials you examined were quite inadequate as indicators of withdrawal problems in clinical practice.

[b] Exemption 13 refers specifically to "unwarranted" disclosure, which you did not. Are you claiming that disclosure would be unwarranted and, if so, on what basis have you concluded this?

[c] My reading of this exemption is that it would apply only if the requested information contained "commercial confidences, trade secrets or intellectual property". Can we agree on this? If so, are you claiming that any or all of the information I requested would be covered by a "commercial confidence" exemption and, if so, please would you define the meaning of "commercial confidence" you have applied? Ditto "trade secrets" and "intellectual property". If my modest request for information can be refused on such grounds, it would seem to drive not so much coach and horses, as several armoured divisions, through relevant sections of the recent White Paper proposals on freedom on information.

3. You seek to justify your refusal on the grounds that "there is no current risk to public health or safety sufficient to override" the licence holders' commercial interests. If this matter does go to appeal, I would be likely to argue that there is indeed a risk to public health, arising not least from the MCA's tendency to rely on inappropriate methodologies to draw unwarranted conclusions from plainly unreliable data. In the meantime:

[a] Please will you identify that part of the Code which identifies this as an appropriate test?

[b] I cannot reconcile the grounds you state for refusing to disclose with Dr Price's earlier statement that "the MCA will make information available unless there are sound reasons of public interest for not releasing it". Are you now telling me that the perceived lack of any imminent health hazard is the sound reason you have for non-disclosure?

[c] In applying the public interest test mentioned by Dr Price, did you take into account any factors other than those relating to possible drug risk and, if so, what were they?

Finally, I note that your letter does not mention, as part of the appeals procedure, the possibility of referral to an independent assessor. I would not be sorry to learn that the MCA had scrapped this procedure, which I found intensely cumbersome and barely helpful, when I used it last year. However, please would you confirm that this avenue is now closed, and indicate the reasons why it was decided to discontinue it.

Thank you for your attention; I shall look forward to hearing from you.

Yours sincerely,

Charles Medawar


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