| Social Audit Ltd |
| P O Box 111 London NW1 8XG |
 Telephone/Fax 44 (0)171 586 7771 |
| Social Audit Ltd |
| P O Box 111 London NW1 8XG |
| Telephone/Fax 44 (0)171 586 7771 |
| The Secretary, Prescription Medicines | |
| Code of Practice Authority, c/o ABPI | |
| 12 Whitehall | |
| London SW1A 2DY | 26 October 1999 |
Dear Sirs,
I am enclosing a copy of an advertisement for Detrusitol (tolterodine, P&U), from the current edition of the British Medical Journal. I should like to enquire if the claims it makes and implies would be considered by the PMCPA to be "accurate, balanced, fair, objective and unambiguous", within the meaning of the Code (7.2).
The reason for doubting it is that the advertisement fails to reflect the important evidence relating to lack of efficacy and/or the modest drug effect that appears in the following table in the Data Sheet/Summary of Product Characteristics. This indicates that fewer than two patients in ten experienced "no or minimal bladder problems after treatment" - very few more than the numbers who recovered without the drug (i.e. on placebo).
VARIABLE |
4-WEEK STUDIES |
8-WEEK STUDIES |
||||
Detrusitol 2mg b.i.d |
Placebo |
Statistical significance vs, placebo |
Detrusitol 2mg b.i.d |
Placebo |
Statistical significance vs, placebo |
|
No. of micturitions per 24 hours |
-1.6 (-14%) n=392 |
-0.9 (-8%) n=198 |
* |
-2.3 (-20%) n=354 |
-1.4 (-12%) n=176 |
** |
No. of incontinence episodes per 24 hours |
-1.3 (-38%) n=288 |
-1.0 (-26%) n=151 |
n.s. |
-1.6 (-47%) n=299 |
-1.1 (-32%) n=145 |
* |
Mean volume voided per micturition (ml) |
+25 (+17%) n=385 |
+12 (+8%) n=185 |
*** |
+35 (+22%) n=354 |
+10 (+6%) n=176 |
*** |
Number of patients with no or minimal bladder problems after treatment (%) |
16% n=394 |
7% n=190 |
** |
19% n=365 |
15% n=177 |
n.s. |
(n.s. = not significant * = p# 0.05 ** = p# 0.01 *** = p# 0.001)
The advertisement includes prominent claims such as, "Freed by Detrusitol", "help free your patients from the restrictions of unstable bladder", and "Detrusitol effectively and selectively relieves frequency, urgency and/or urge incontinence". Such claims would seem to apply to only a small percentage of the patients treated with this drug; my contention is that doctors would need to know this, and that the advertisement is not strictly accurate, nor balanced, nor fair to either doctors or patients, not objective, and far from unambiguous.
Thank you for your attention. I look forward to hearing from you.
| Yours sincerely, |
| Charles Medawar |
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