Case AUTH/949/10/99: Advertisement for Detrusitol

Thank you for your letter of 4 February. I'm quite happy for you to identify Social Audit as the complainant, and this has caused no inconvenience. I appreciate your offer to send the Code of Practice Review in future. We would like to be put on your mailing list, but hope it won't be long before COPA reports can be accessed on the Internet.

In the meantime, I am enclosing some information obtained since I last wrote, that may be of interest to your Panel. Please find enclosed copies of "Warning Letters" dated 9 February, 1 April and 29 May 1998, and 13 April 1999, sent to Pharmacia & Upjohn by the US Food & Drug Administration - all complaining about the advertising of Detrol (ie tolterodine). You will see that FDA considered P&U's advertising misleading on numerous counts - most recently because claims made for the "selective" action of tolterodine were based not on human studies, but on experiments on guinea pigs and cats ...

I wondered if the Panel would have been aware of these problems at the time it was considering the case we referred to you? If not, it occurs to me that it might be useful to require any company under investigation to provide details of all complaints made against the relevant product(s) in other jurisdictions.

In any case, I would be interested to know whether the COPA Panel would be inclined to take account of any related findings against a company in considering what sanctions might be appropriate. You may have seen the comment on the Detrusitol case by a P&U spokesperson, suggesting that this breach was really nothing much to worry about:

"It was simply a dispute over whether 'the data is capable of supporting this kind of language. In any system of regulation you are going to find cases where people say 'not on this occasion'.' " (Guardian, 31/1/00, p.6)

To me this suggests that P&U are not only missing the point, but making rather a habit of it. I shall look forward to reading the Panel's ruling in due course.

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