|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)171 586 7771|
|Mr Roy Alder, Head of Executive Support|
|Medicines Control Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||
26 October 1999
Dear Mr Alder,
I am enclosing with this letter a copy of the complaint I have today sent to the Prescription Medicines Code of Practice Committee, about an advertisement for Detrusitol (tolterodine, P&U) in the current BMJ. I have also enclosed some relevant papers about DTC advertising.
Independently of this complaint, I should like to raise a number of questions about the terms on which this product was licensed. Please treat these as formal requests under the Code of Practice on Access to Government Information:
1. Given that the large majority of users stand to gain no real benefit from this drug, but would be exposed to the risk of adverse effects, I should like to know more about the basis on which the drug was licensed. Please supply a copy of the full terms of the license for this product, together with the minute(s) of any CSM (or sub-committees) discussion about the safety/efficacy of this product, held within the past five years.
2. Is the MCA satisfied that this advertisement for Detrusitol "is not inconsistent with the particulars contained in the Data Sheet" [Medicines Act, s. 96 (3) (b)], and not "likely to mislead as to the nature or quality or effects" of this drug [s. 93 (7) (b)]? If the MCA is not satisfied, what steps will be taken to enforce these provisions of the Act?
3. What justification can there be for the lack of guidance in the data sheet about recommended duration of treatment - apart from the statement that "after 6 months the need for further treatment should be considered" - when evidence in the table suggests [a] that reliable efficacy data is available only for 4-week and 12-week studies; that [b] there is only marginal extra benefit from the drug beyond 4-weeks of treatment; and that [c] the conditions for which the drug is prescribed tend to spontaneous remission (increased placebo response between four and twelve weeks)?
4. It seems to me very unusual to find such bald evidence of limited efficacy in a Data Sheet/SPC, and it seems safe to assume that the Table was inserted at the insistence of the licensing authorities and against the wishes of the License holder. Can you please confirm this, indicating also whether this signals some general change of policy by the MCA/CSM - i.e. that more data on lack of efficacy should be included in Data Sheets/SPCs?
Thank you for your attention. I shall look forward to hearing from you.
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