| 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 |
| Mr Roy Alder, Head of Executive Support | |
| Medicines Control Agency | |
| Market Towers, 1 Nine Elms Lane | |
| London SW8 5NQ | 14 February 2000 |
Dear Mr Alder,
RE: PROMOTION OF DETRUSITOL (TOLTERODINE, PHARMACIA & UPJOHN)
Since writing to you on 30 January, I have obtained copies of four "Warning Letters" sent to the manufacturers of this product by the US Food & Drug Administration (FDA) in 1998 and 1999. I am enclosing copies; they detail complaints by the FDA Division of Drug Marketing, Advertising and Communications (DDMAC) of numerous misleading promotional claims. No nonsense here about claims being "potentially misleading"; these letters come to the point:
9 February 1998: Complaint about pre-approval promotion of Detrusitol and unsupported claims of effectiveness and superiority over other drug products. (http://www.fda.gov/cder/warn/feb98/6302.pdf)
1 April 1998: Complaint about misleading claims in a P&U press release relating to the alleged uniqueness and superiority of the product (http://www.fda.gov/cder/warn/apr98/6493.pdf)
29 May 1998: Complaint that advertising is misleading by "overstatement of efficacy" and "selective presentation of data" (http://www.fda.gov/cder/warn/may98/6710.pdf)
13 April 1999: Complaints about misleading claims in the product monograph (brochure), resulting to omission of material facts, dosing regimens and selectivity of action (http://www.fda.gov/cder/warn/apr99/7844.pdf):
| "Detrol - Therapy Selective for overactive bladder" |
| "Selective for overactive bladder" |
| "Demonstrates a selectivity for bladder vs salivary glands" |
| "Exhibits a potent antimuscarinic action on the bladder" |
| "Greater tissue distribution in bladder vs CNS" |
"P&U prominently presents these claims either as headlines or in bold type throughout the brochure. Detrol's approved product labeling states that the drug shows selectivity for the urinary bladder over salivary glands in cats (emphasis added). It has not been demonstrated in adequate and well-controlled clinical studies that Detrol is more selective for the bladder in humans …"
In the current Data Sheet/SPC, the relevant passage states that "Tolterodine is a competitive, specific cholinergic receptor antagonist with a selectivity for the urinary bladder rather than salivary glands in vivo". Now why would the MCA/CSM allow the company to gloss over the fact that these in vivo studies involved cats rather humans - when at the same time they are striving to have useful efficacy data deleted from the Data Sheet/SPC? Beats me.
And what does the MCA/CSM's post-marketing surveillance for new medicines really amount to? Would I be right in thinking that scrutiny of promotional claims is an occasional, rather than systematic endeavour - involving not really much more than referring complaints received from elsewhere, either to the company or the Code of Practice Authority? I imagine that the resources for such work available to the MCA/CSM would be tiny in relation to those of the FDA, but perhaps you could tell me how many person hours per day (or other appropriate measure) the MCA typically devotes to such work?
I'd also like to know whether or not the MCA/CSM [a] had scrutinised the P&U product monograph for Detrusitol; and [b] were aware of the above-mentioned FDA findings, before our complaint was referred to you, in October 1999. Your letter to me of 24 January gave no hint of this - but you did write that the MCA had considered the advertisement we sent "together with other advertisements". May I please know if any adverse findings relating to these were communicated to the Company? If so may I please formally request a copy of the letter(s) or communications sent?
You will appreciate that my underlying concern is more to do with the damaging effects of direct to consumer advertising (DTCA) in the UK, than with this particular product. It may be that DTCA would be less damaging in the USA - because of extensive enforcement and regulatory activity and effective freedom of information laws. In Britain - with the prospect of neither - it is easy to imagine that DTCA might do a great deal more harm.
Apropos of this, please would you let me have copies of, or any information you can about, any MCA/CSM consideration or assessment of the implications or impact of DTCA, whether in the UK or EU.
Thank you for your attention. I look forward to hearing from you.
| Yours sincerely, | |
| Charles Medawar |
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